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CONTENTS
1. GENERAL INTRODUCTION AND SCOPE OF PHARMACOGNOSY 3
2. CRUDE DRUGS 10
3. EVALUATION AND ADULTERATION OF CRUDE DRUGS 19
5. DRUGS OF ANIMAL ORIGIN 38
6. BIOLOGICS 50
7. SURGICAL DRESSINGS 70
8. PESTICIDES 77
9. GROWTH REGULATORS 98
10. POISONOUS PLANTS INCLUDING ALLERGANS AND 108
ALLERGIC PREPARATIONS
11. ENZYMES 129
3. UNIT : 1
GENERAL INTRODUCTION AND SCOPE
OF PHARMACOGNOSY
Pharmacognosy :
• Derived from two Latin words “pharmakon” meaning drug and “gignoso” meaning to acquire
knowledge.
• It means knowledge or science of drugs.
“Pharmacognosy is the study of crude drugs obtained from plant, animal and mineral kingdom, as well
as their constituents.”
• According to the American Society of Pharmacognosy,
“Pharmacognosy is the study of the physical, chemical, biochemical and biological properties of drugs,
drug substances, or potential drugs or drug substances of natural origin as well as the search for new
drugs from natural sources.”
Origin of Pharmacognosy :
• Initially known as materia medica.
• Physician, J.A Schmitt was the first person to use the term materia medica to explain the study
of medicinal plants and their properties.
• The concept of pharmacognosy is as old as the existence of man.
• Plants were the only curative agents available at that time .
• Curative properties were associated with plants after trial and error.
• If something caused diarrhoea, it was used as a purgative.
• Plants were used as decoctions or infusions
History of Pharmacognosy :
• Ancient China: Shen Nung, Chinese emperor, investigated the medicinal value of herbs by
testing on himself and wrote a book recording 365 herbs (2700 B.C).
• Podophyllum, rhubarb, ginseng are his recorded drugs that are still being used.
• Ancient Egypt: The most well documented compilations were put together in Egypt at that time.
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• Ebers Papyrus (1550 B.C) contained 800 prescriptions containing 700 drugs.
• Edwin Smith Papyrus (1600 B.C) contained surgical instructions and cosmetic formulations.
• Kahun Medical Papyrus (1900 B.C) contained details of women heath including birthing
instructions.
• Commonly used herbs were senna, honey, pomegranate roots, etc.
• Ancient India: Ayurveda is the term used for ancient Indian medicine.
• It means the study of life.
• Out of all the writings, Charaka Samhita is assumed to be the most important writing on
Ayurveda.
• Ricinus, black pepper, valerian, etc. are a few of the plants mentioned.
• Ancient Greece and Rome: most advancements made by Greek scientists.
• Isolation, structural elucidation and study of constituents took place.
Scope of Pharmacognosy :
Crude drugs of natural origin that is obtained from plants, animals and mineral sources and their active
chemical constituents are the core subject matter of pharmacognosy.
• These are also used for the treatment of various diseases besides being used in cosmetic, textile
and food industries.
• During the first half of the nineteenth century apothecaries stocked the crude drugs for the
preparation of herbal tea mixtures, all kinds of tinctures, extracts and juices which in turn were
employed in preparing medicinal drops, syrups, infusions, ointments and liniments.
• The second half of the nineteenth century brought with it a number of important discoveries in
the newly developing fields of chemistry and witnessed the rapid progress of this science.
• Medicinal plants became one of its major objects of interest and in time, phytochemists
succeeded in isolating the pure active constituents.
• These active constituents replaced the crude drugs, with the development of semisynthetic and
synthetic medicine, they became predominant and gradually pushed the herbal drugs, which
had formerly been used, into the background.
• It was a belief that the medicinal plants are of no importance and can be replaced by man-made
synthetic drugs, which in today’s scenario is no longer tenable.The drug plants, which were
rapidly falling into disuse a century ago, are regaining their rightful place in medicine.
• Today applied science of pharmacognosy has a far better knowledge of the active constituents
and their prominent therapeutic activity on the human beings.
• Researchers are exploiting not only the classical plants but also related species all over the world
that may contain similar types of constituents. Just like terrestrial germplasm, investigators had
also diverted their attention to marine flora and fauna, and wonderful marine natural products
and their activities have been studied.
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• Genetic engineering and tissue culture biotechnology have already been successful for the
production of genetically engineered molecules and biotransformed natural products,
respectively.
• Lastly, crude drugs and their products are of economical importance and profitable commercial
products. When these were collected from wild sources, the amount collected could only be
small, and the price commanded was exorbitantly high. All this has now changed.
• Many of the industrially important species which produced equally large economic profits are
cultivated for large-scale crop production.
• Drug plants, standardized extracts and the therapeutically active pure constituents have become
a significant market commodity in the international trade.
• In the light of these glorious facts, scope of pharmacognosy seems to be enormous in the field
of medicine, bulk drugs, food supplements, pharmaceutical necessities, pesticides, dyes, tissue
culture biotechnology, engineering and so on.
• Scope for doctoral graduates in pharmacognosy is going to increase in the coming years.
The pharmacognosist would serve in various aspects as follows:
• Academics: Teaching in colleges, universities, museums and botanical gardens.
• Private industry: Pharmaceutical companies, consumer products testing laboratories and
private commercial testing laboratories, the herbal product industries, the cosmetic and
perfume industries, etc.
• Government: Placement in federal agencies, such as the Drug Enforcement Agency, the Food
and Drug Admin-istration, the U.S. Department of Agriculture, Medicinal plant research
laboratories, state agencies like forensic laboratories, environmental laboratories, etc.
Undoubtedly, the plant kingdom still holds large number of species with medicinal value which have yet
to be discovered. Lots of plants were screened for their pharmacological values like, hypoglycaemic,
hepatoprotective, hypotensive, antiinflammatory, antifertility, etc. pharmacognosists with a
multidisciplinary background are able to make valuable contributions in the field of phytomedicines.
COMMON TERMINOLOGY USED IN PHARMACOGNOSY :
Crude Drugs: Plant or animal drugs that have only undergone collection and drying or cut into
transverse or longitudinal sections or peeled in some cases.
Organized Drugs: Direct parts of plants and consist of cellular tissues.
Unorganized Drugs: They’re prepared from plants or animals but not a direct part of plants and
prepared by some intermediary physical process like incision, drying or extraction.
Extraction: The process of isolation of soluble material from insoluble residue , using a solvent.
Pharmacopoeia: Official document containing medicinal drugs along with their effects and direction of
use.
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Herbs: Short plants with delicate stems and die down to the ground after production of fruit and seeds.
Shrub: A woody plant shorter than a tree.
Root: Underground organ of plant that transports minerals and water to the plant and acts as an anchor
for the plant.
Stem: The structure that holds the leaves and transports food and water to the leaves via vascular
bundles.
Leaves: The organs of the plant that synthesize food for the entire plant.
Rhizome: Horizontal underground plant stem capable of producing the root and shoot systems of a new
plant.
Adulteration: Substitution of original crude drug with similar impurity.
PHARMACOGNOSTIC SCHEME :
Biological Source: The official names of the plant or animals (biological names).For example: Acacia
arabica.
Family and part used.
Geographical Source: The area of cultivation and collection. For example: Papaver somniferum is grown
in Northern Pakistan.
Cultivation, Collection and Preparation: How and when the plant is cultivated, how and when the plant
is collected and how the plant is prepared for use.
Morphological Characteristics: The length, breadth, thickness, colour, odour, taste, shape, etc.
Microscopic Characteristics: Explains how the plant features look under a microscope.
Chemical Constituents: The drugs that contain medicinal chemical constituents are physiologically
active.
Uses: the pharmaceutical, pharmacological and biological activity.
Substituents: the alternate drug that can be used in case of non-availability.
Adulterants: impurities that can be added to the pure plant material.
Chemical Tests: which chemical tests should be performed for identification. Very important for
unorganized drugs because their morphology is not well defined.
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INTRODUCTION TO TRADITIONAL MEDICINE SYSTEMS :
Earlier civilizations developed their own medicine systems based on their beliefs and philosophies. Some
are still in use today. These medicine systems are called traditional medicine systems or alternative
medicine systems.
This is also known as complementary and alternative medicine (CAM) The traditional medicine systems
to be discussed are:
• Unani Sytem of Medicine
• Ayurvedic System of Medicine
• Homeopathic System of Medicine
UNANI SYSTEM OF MEDICINE :
• Originated in Greece, by Greek philosopher and physician, Hippocrates as he gave medicine the
status of science.
• After him, other Greek scholars followed him and Galen stabilized this foundation.
• Arab physicians, including Raazes and Avicenna played a huge role in building upon this
foundation.
• The Arabs brought this system to India (sub-continent) and was firmly rooted by Muslim
scientists/physicians.
• The basic principles of Unani medicine state that the body is made up of 4 elements.
• These elements have 4 temperaments: ▪Hot ▪Cold ▪Dry ▪Wet
• The organs are simple or compound which get their nourishment through 4 humours: ▪Blood
▪Phlegm ▪Yellow Bile ▪Black Bile
“Health is a state of body in which there is equilibrium in the humours and functions of the body are
normal in accordance to its own temperament and the environment.”
AYURVEDIC SYSTEM OF MEDICINE :
• One of the medicine systems of India and the oldest medicine system.
• Charaka Samhita was the first recorded book on Ayurveda and mentioned 341 plants.
• The principle of the Ayurvedic system of medicine is that the universe is composed of 5
elements or pancha bhutas, which are: ▪Earth ▪Water ▪Fire ▪Air ▪Space.
• Everything in the universe is made up of these 5 elements so a fundamental harmony exists
between the universe and the individual.
• The human body is in state of continuous flux or dynamic equilibrium.
• The pancha bhutas are represented in the body as doshas (humours), dhatus (tissues) and malas
(by-products of dhatus).
• Disease in Ayurveda is the reaction between body humours and tissues which is influenced by
the environment.
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HOMEOPATHIC SYSTEM OF MEDICINE :
• Specialized system of therapeutics developed by German physician, chemist and pharmacist, Dr.
Samuel Christian Friedrich Hahnemann.
• Based on the principle “likes are cured by likes”.
• “Homois” means similar and “pathos” means treatment.
• Homeopathy is the system of treating disease or suffering by the administration of drugs that
have the capability of producing similar disease or suffering in healthy humans.
• It is believed that symptoms are the reflection of the inner fight of the body towards the disease
and not the manifestation of the disease.
FUNDAMENTAL PRINCIPLES OF HOMEOPATHY:
• Law of Similia
• Law of Simplex
• Law of Minimum
• Drug proving
• Drug dynamization or drug potentization
• Vital force
• Acute and chronic disease
• Individualization
• Direction of cure
Introduction to Herbal Pharmacopoeias :
A pharmacopoeia is a reference book for the preparation of quality medicines published by the
authority of a government or a concerned society.
A herbal pharmacopoeia represents qualitative and therapeutic details on botanicals.
May also contain the description of preparation of a plant.
Herbal Monograph :
Defines the botanical drug and provides information regarding its proper identification.
Contains the basic description including: Nomenclature, Part used, Constituents, Range of application,
Contraindications and side effects, Incompatibilities with other medication, Dosage, Uses, Action of the
herb.
Herbal pharmacopoeias intend to promote the responsible use of herbal medicines with high efficacy
through development of standards of identity, purity and analysis of botanicals .
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Examples of Herbal Pharmacopoias :
• The American Herbal Pharmacopoeia (AHP)
• The British Pharmacopoeia
• The European Pharmacopoeia
• The Indian Ayurvedic Pharmacopoeia
Modern Concepts of Pharmacognosy :
• According to the American Society of Pharmacognosy,
“Pharmacognosy is the study of the physical, chemical, biochemical and biological properties of drugs,
drug substances, or potential drugs or drug substances of natural origin as well as the search for new
drugs from natural sources.”
• In modern domain, animals, bacteria, fungi, marine organisms and minerals are also promising
sources of medicines.
• The advancements in analytical techniques, phytochemistry, pharmacology, drug discovery and
biotechnology have been very beneficial to pharmacognostic research.
• The development in advancements in analytical techniques for isolation and purification and
advanced technologies for bioassays and molecular techniques are of great importance in the
field of pharmacognosy .
• There has been an increase in the research and development of natural medicines and natural
products worldwide.
• This has emphasized the isolation and structural elucidation of active constituents of natural
resources.
• Biochemistry, pharmacology and molecular biology are an essential part of modern
pharmacognosy.
• Pharmacognosy has become one of the core streams of pharmaceutical research and
education.
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UNIT : 2
CRUDE DRUGS
CRUDE DRUGS :
Crude drugs are vegetable or animal drugs that consist of natural substances that have undergone only
the processes of collection and drying.
PREPARATION OF CRUDE DRUGS :
It has the following steps
• Collection
• Harvesting
• Drying
• Garbling
• Packaging, Storage and Preservation
COLLECTION:
• Collection of drugs from cultivated plants always ensures a true natural source and a reliable
product. This may or may not be the case when drugs are collected from wild plants.
• Carelessness or ignorance on the part of the collector can result in complete or partial
substitution.
• This is especially true when drugs are difficult to collect or the natural source is scarce.
• Many drugs are collected from wild plants, sometimes on a fairly extensive scale (tragacanth,
senna) when collection is the vocation of the gatherer, and sometimes on a limited scale when
collection is an avocation (podophyllum, hydrastis).
• Because drugs come from all over the world, collection areas are almost universal, and
collectors may vary from uneducated natives to highly skilled botanists.
• Certain areas of the United States are particularly noteworthy as collection areas.
• Whit pine, podophyllum, ginseng, and many other native American drugs are collected in the
Blue Ridge Mountain region, of which Asheville, North Carolina, is one of the important
collection areas.
• Native American drugs are usually collected by individuals, such as farm children and part time
agricultural laborers.
• The proper time of harvesting or collecting is particularly important because the nature and
quantity of constituents vary greatly in some species according to the season.
• The most advantageous collecton time is when the part of the plant that constitutes the drug is
highest in its content of active principles and when the material will dry to give the maximum
quality and apearance.
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HARVESTING:
• The mode of harvesting varies with each drug produced and with the pharmaceutic
requirements of each drug.
• Some drugs may be collected by hand labor; however, when the cost of labor is an important
factor, the use of mechanical devices is often more successful in economic production of the
drug.
• With some drugs, where the skillful selection of plant parts is an important factor (digitalis),
mechanical means cannot replace hand labor.
DRYING:
• By drying the plant material, one removes sufficient moisture to ensure good keeping qualities
and to prevent molding, the action of enzymes, the action of bacteria, and chemical or other
possible changes.
• Drying fixes the constituents, facilitates grinding and milling, and converts the drug into a more
convenient form for commercial handling.
• Proper and successful drying involves two main principles: control of temperature and
regulation of air flow.
• Control of the drying operation is determined by the nature of the material to be dried and by
the desired appearance of the finished product.
• The plant material can be dried either by the sun or by the use of artificial heat.
• With some natural products, such as vanilla, processes of fermentation or sweating are
necessary to bring about changes in the constituents.
• Such drugs require special drying processes, usually called "curing."
GARBLING:
• Garbling is the final step in the preparation of a crude drug.
• Garbling consists of the removal of extraneous matter, such as other parts of the plant, dirt, and
added adulterants.
• This step is done to some extent during collection, but should he carried out after the drug is
dried and before it is baled or packaged.
• Although garbling may be done by mechanical means in some cases, it is usually a semiskilled
operation.
PACKAGING, STORAGE AND PREVENTION:
• The packaging of drugs depends on their final disposition.
• In commerce, if transportation, storage, and ultimate use for manufacturing purposes are
involved, it is customary to choose the type of packaging that provides ample protection to the
drug and gives economy of space.
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Examples:
• Leaf and herb material is usually baled with power balers into a solid compact mass that is then
sewn into a burlap cover.
• Bales that are shipped overseas weigh from 100 to 250 lb.
• Senna leaves from India come in bales of 400 lb; stramonium from Argentina in bales of 700 lb.
• Drugs that are likely to deteriorate from absorbed moisture (digitalis, ergot) are packed in
moisture proof cans.
• Gums, resins, and extracts are shipped in barrels, boxes, or casks.
Packaging of Drugs:
• Packaging is often characteristic for certain drugs.
• The standard package for all grades of aloe is a 55-gallon steel drum, and this type of container
is also employed for balsam of Peru.
• Matting-covered packages of cinnamon from the Far East, seroons (bales covered with cowhide)
containing sarsaparilla from South America, lead flasks with oil of rose from Bulgaria, and many
other odd forms of packaging are noted in the drug trade.
Storage and Prevention:
• Proper storage and preservation are important factors in maintaining a high degree of quality, of
the drug.
• Hard-packed bales, barks, and resinous drugs usually reabsorb little moisture.
• But leaf, herb, and root drugs that are not well packed tend to absorb amounts of moisture that
reach 10,15, or even 30% of the weight of the drug.
• Excessive moisture not only increases the weight of the drug, thus reducing the percentage of
active constituents, but also favors enzymatic activity and facilitates fungal growth.
Prevention from light on Drugs:
• Light adversely affects drugs that are highly colored, rendering them unattractive and
possiblcrsing undesirable changes in constituents.
• The oxygen of the air increases oxidation of the constituents of drugs, especially when oxidases
are present.
• Therefore, the warehouse should be cool, dark, and well ventilated with dry air.
• The protection of drugs against attacks by insects must not be overlooked.
• The insects that infest vegetable drugs belong chiefly to the orders Lepidoptera, Coleoptera, and
Dip tera.
Prevention from Insects:
• For destruction of insects and prevention of theirttcks, a number of methods have been
employed.
• The simplest method is to expose the drug to a temperature of 65°C.
• This method is probably the most efficient not only in preventing insect attacks but also in
prventing many other forms of dedeterioration.
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• For the fumigation of large lots of crude drugs, such as those stored in warehouses and
manufacturing plants, the use of methyl bromide has met with considerable success.
Storage of small lots of Drugs:
• Small lots of drugs may readily be stored in tight, light-resistant containers.
• Tin cans, covered metal bins, or amber glass containers are the most satisfactory.
• Drugs should not be stored in wooden boxes or in drawers and never in paper bags.
• Not only is deterioration hastened, but odors are communicated from one drug to another,
attacks by insects are facilitated, and destruction by mice and rats may occur.
• If drugs in small quantities are stored in tight containers, insect attack can be controled by
adding to the container a few drops of chloroform or carbon tetrachloride from time to time.
Prevention of Drugs from Moisture:
• In the case of digitalis and ergot, whose low moisture content must be maintained at all times, a
suitable Catridge or device containing a nonliquefing, inert, dehydrating substance may be
introduced into the tight container. Because high temperatures accelerate all chemical
reactions, including those involved in deterioration, drugs must always be stored at cool
temperature as possible. The ideal temperature is just above freezing, but since this is
impractical in most cases, the warehouse or other storage place should be cool as possible.
Prevention of Drugs from Temperature:
• Temperatre also effects the drugs.
• Certain drugs, such as the biologics, must be stored at a temperature between 20 and 8°C.
CLASSIFICATION OF CRUDE DRUGS:
• Higher plants, microbes and animals are the main sources of crude drugs.
• However, enzymes and antibiotics used in modern medicine are obtained from animals and
microbes.
• For the study of crude drugs, they may be classified according to morphological, taxonomical,
chemical and pharmacological characters.
• Each of these systems has its own merits and demerits.
• Morphological classification is more helpful to identify and detect adulteration.
• For studying evaluationaiy developments, the drugs are classified according to taxonomical
classification.
• The activity of a drug is due to its chemical constituents and, therefore, the drugs are divided
according to the presence of chemical components.
• Pharmacological classificatinn of drugs is more relevant to study therapeutic utility of the drugs.
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MORPHOLOGICAL CLASSIFICATION:
Under morphological classification the drugs are arranged according to the part of the plant used such
as leaves, stems, roots, barks, flowers, seeds. etc.
Organized Drugs:
The drugs obtained from the direct parts of the plants and containing cellular tissues are called as
organized drug.
Example: Rhizomes, barks, leaves, fruits, entire plants, hair and fibres.
Unorganized Drugs:
The drugs which are prepared from plants by some intermediate physical processes such as incision,
drying, or extraction with a solvent and not containing any cellular plant tissues are called as
unorganized drugs.
Example: Aloe juice. Opium latex.
Drawback of Morphological Classification:
• The main drawback of morphological classification is that there is no co-relation of chemical
constituents with the therapeutic actions.
• Usually this classification is adopted in the practical classes.
Gross Classification of Drugs on the Basis of Morphological
Characteristics
Organized Drugs:
PLANT PARTS DRUGS
Wood Quassia, Sandalwood, Red Sandalwood
Leaves Digitalis. Eucalyptus. Gurmar.
Pudina, Selina, Spearmint. Squill.
Tulsi. Vasaka. Coca. Buchu.
Hamamelis, Hyoscyamus,
Belladonna. Tea.
Barks Arjuna. Ashoka. Cascara. Cassia.
Cinchona, Cinnamon, Kurchi,
Quillaia. Wild Cherry.
Flowering Parts Clove. Pyrethrum. Saffron,
Santonica, Chamomile
Fruits Amla, Anise, Bael, Bahera. Bitter
Orange peel, Capsicum, Caraway,
Cardamom, Cassia, Colocynth,
Coriander, Cumin, Dill, Fennel,
Gokhru, Hirda, Lemon peel.
Psoralea. Senna pod. Star anise.
Tamarind, Vidang.
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TAXANOMICAL CLASSIFICATION:
• Taxonomical classification is based on the principles of natural relationship and evolutionary
development.
• They are grouped in phyllum order, family, genus and species.
• As all the entire plants are not used as drugs, therefore, it is of no significance of this division
from identification point of view.
• This system also does not co-relate in between the chemical constituents and biological activity
of the drugs.
PHYLUM ORDER FAMILY DRUGS
Magnoliopsida
(dicotyledons)
Solanales Solanaceae Belladonna,
Hyoscyamus leaf,
Stramonium, Capsicum
Liliopsida Zingiberales Zingiberaceae Ginger, Curcuma
CHEMICAL CLASSIFICATION:
• The biological activity of a drug is due to the presence of certain chemical constituents In the
drug. Plants and animals synthesize chemical compounds such as fats, carbohydrates, proteins,
volatile oils, alkaloids, resins,etc. and some of these are pharmacologically active constituents.
• A single active constituent may be isolated from the crude drug and used as a medicinal agent.
• More than 75 pure compounds derived from higher plants find their place In modern medicine.
• For example, the important traditional active plant principles are codeine, atropine, ephedrine,
hyoscyamine, digoxin, hyoscine, digitoxin, pilocarpine, theobromine, theophylline, quinidine,
quinine, emetine, caffeine, papaverine and colchicine.
• These active constituents are differentiated from the inert compounds like starch, cellulose,
lignin, cutin, etc.
• The active constituent may be present in a very low concentration in the drug.
CHEMICAL CONSTITEUNTS DRUGS
Carbohydrates Acacia, Tragacanth, Honey, Starch, Agar, Pectin
Glycosides Aloe, Cascara, Rhubarb, Senna, Glycyrrhiza
Tannins Amla, Pale Catechu, Black Cathechu
Volatile Oils Cinnamon, Nutmeg, Fennel, Caraway, Coriander,
Mint
Lipids Castor, Almond, Theobroma, Cottonseed
Proteins Gelatin, Papain
Vitamins Yeast
Triterpenes Rasna, Colocynth
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PHARMACOLOGICAL CLASSIFICATION:
• In Pharmacological classification the drugs are grouped according to their therapeutic uses.
• Thus cardiotonic drugs include Digitalis, Squill and Strophanthus.
• Senna leaves and Castor oil are termed as purgative drugs.
• A particular drug containing known chemical constituents can be grouped according to its
therapeutic use.
• The main drawback of this classification is that a drug can be placed in various classes according
to its therapeutic use.
• Thus Cinchona can be grouped in antimalarial and antlarrhythmic catagories.
PHARMACOLOGICAL ACTIONS DRUGS
Anticancer Vinca, Podophyllum. Taxus
Anti-inflammatory Colchicum corm and seed, Turmeric
Antiamoebic Ipecac root. Kurchi bark
Anthelmintic Artemisia. Male Fern, Quassia wood.
Vidang. Chenopodium oil
Antiasthmatic Ephedra, Lobelia. Vasaka, Tylophora
Astringent Catechu. Tannic acid. Myrrh.
Myrobalan, Ashoka bark
Analgesic Opium, Cannabis
Bitter Tonics Quassia wood, Nux-vomica, Gentian,
Picrorhiza, Chirata, Kalmegh
Carminatives Cinnamon bark. Cardamom seed,
Flavours Nutmeg fruit, Clove. Umbelliferous
fruits. Peppermint. Saffron,
Asafoetida, Oleo-gum resin, Mint.
Tulsi, Ginger, Vanilla
Purgatives Cascara bark. Senna, Rhubarb,
Aloe. Castor oil, Plantago seed husk
Expectorant Benzoin. Balsam of Tolu,
Glycyrrhiza, Vasaka
Cardiotonic Digitalis, Squill, Strophanthus
CNS Action Ergot, Belladonna, Stramonium.
Hyoscyamus, Ephedra, Physostigma
Hallucinogens Cocaine, Cannabis.
Tranquillizer Rauwolfia roots.
COMMERCE IN DRUGS:
“The commercial origin of a drug refers to its production and its channels of trade.”
• Drugs frequently bear a geographic name indicating the country or region in which they are
collected, the country or city from which they are shipped, or their variety.
• These names do not necessarily reflect the area where the plant grows.
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• English hyoscyamus leaves are gathered from plants growing in England and are principally
consumed in that country; Indian rhubarb is the product of plants growing in various parts of
India; Spanish licorice is a botanic variety of Glycyrrhiza glabra, originally produced in Spain but
now produced elsewhere; and Oregon grape root is a species of Mahonia and may or may not
come from Oregon. The commercial origin may change in the course of time, as with cinchona,
vanilla, and coca previously mentioned.
• Since World War II, most of the drug items have been shipped directly from the producing areas
to New York City.
• Although many drug collectors and dealers conducted their business through a governmental
agency in the past, little drug commerce now passes through such an agency.
• The exceptions are the communist countries and their European satellites, where governmental
agencies control all commerce.
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UNIT 4
EVALUATION AND ADULTERATION OF
CRUDE DRUGS
EVALUATION OF CRUDE DRUGS
• Evaluation of drugs deals with the correct identification of the plant and determination of
quality and purity of the crude drugs.
• Actual collection of the drug is done from the identified plant or animal.
• For this purpose research gardens have been maintained.
• The characters of an unknown sample are compared with the authentic monographs written In
the pharmacopoeia.
• The high quality of the drug is maintained by collection of the drug from the correct natural
source at
• proper time: preparation of samples of the collected drugs by proper cleaning, drying and to
free from dirt, and proper preservation of the cleaned, dried and pure drug.
• The evaluation of a drug Is done by studying Its organoleptic, microscopic, biological, chemical,
and physical properties.
ORGANOLEPTIC EVALUATION:
Organoleptic evaluation means study of a drug with the help of organs of sense which Includes Its
external morphology, colour, odour, taste, sound of its fracture, etc.
Morphological Characters : To study morphology of a drug, its shape and size, colour and external
markings, fracture and internal colour, odour and taste are examined.
The organized drugs are classified into;
1. Barks: Which are tissues In a woody stem outside the inner fascicular cambium, e.g., Cinnamon,
Cinchona, Quillaia, Ashoka and Kurchi.
2. Underground Structures : Which may be rhizomes, roots, bulbs, corm, and tubers: they are
often swollen due to storage of carbohydrates and other chemicals, e.g., roots (Podophyllum.
Liquorice, Jatamansi, Rauwolfia), rhizomes and stolons which are underground stems and have
buds, scale leaves and scars. (Ginger, Turmeric, Dioscorea).
3. Leaves : These are photosynthetic organs arising from node on a stem. The shape, margin, base,
apex and venation of leaves help In the Identification of the drugs. Senna, Tulsi, Vasaka and
Digitalis leaves can be easily identified.
4. Flowers These are reproductive organs of a plant and possess different shapes, size and colour,
e.g.. Saffron. Banafsha. Pyrethrum.
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5. Fruits : Fruits arise from the ovary and contain seeds, e.g. Cardamom, Colocynth, Almond,
Vidang, Bahera, Arnia and Bael.
6. Seeds : Seeds are developed from the ovules in carpets of the flowers and characterized by the
hilum, micropyle and sometimes raphe. The seed drugs are Ispaghula, Linseed, Nux-vomica,
Psoralia.
7. Herbs : The whole aerial part is sometimes used as a drug, e.g. Brahmi, Chirata, Kalmegh.
Pudina, Shankhpushpi. etc.
The shape of a drug may be cylindrical (Sarsaparilla), sub-cylindrical (Podophyllum). conical (Aconite):
fusiform, ovoid or pyriform (Jalap), and terete or disk-shaped (Nuxvomica).
The drug may be simple, branched, curved or twisted. The length, breadth and diameter are measured
in millimeters or centimeters.
In case of conical drugs the size of both parts is mentioned.
External markings are mentioned as
• furrows, ridges, etc.,
• wrinkles,
• annulations,
• fissures,
• nodules,
• projections,
• scars of leaf, stem-base, root, bud, bud-scale, etc.
The fractures may be complete, Incomplete, short. fibrous, splintery (breaking irregularly), brittle (easily
broken), tough and weak.
Sensory Characters :
• Colour, texture, odour and taste are useful in the evaluation of drugs.
• This method is especially applicable to drugs containing volatile oils or pungent principles (e.g.
Capsicum), and to the detection of the effects of inadequate drying or damp storage.
• The external colour varies from white to yellowish grey, brown, orange or brownish black.
• The colour of some drugs changes if they are dried in sunlight In place of shade.
Odour of a a Drug:
• The odour of a drug may be either distinct (characterisic) or indistinct.
• The terms used to define odour are aromatic, balsamic, spicy, alliaceous (garlic-like),
camphoraceous
• (camphor-like), terebinthinate (turpentine-like) and others.
• Leaves of different species of Mentha can be distinguished by smell.
• Clove and exhausted clove are differentiated by odour.
• Deteriorated Cantharides have ammonical smell while spoiled Ergot has rancid and ammonical
smell.
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Taste of a Drug:
• Taste is a particular sensation production by certain substances when these come Into contact
with taste buds present in epithelial layer of the mouth.
• The taste may be sour (acidic), salty (saline), sweet (saccharine), bitter, alkaline and metallic.
• Substances possessing no taste are mentioned as tasteless.
• The tastes due to a characteristic odour are grouped as aromatic, balsamic, spicy, alliaceous,
camphoraceous and terebinthinate.
• The taste produced by distinctive sensations to the tongue are classified as mucilaginous, oily,
astringent (producing a contraction of the tissues of the mouth), pungent (warm biting
sensation), acrid (unpleasant, irritating sensation) and nauseous (causing vomiting).
• The drugs like Ginger and Capsicum have pungent taste; Gentian, Chirata and Kalmegh have
bitter taste: Glycyrrhiza and Honey are sweet in taste.
• Linseed and Isphagula are mucilaginous: fixed oils have bland taste; calcium oxide is astringent;
Podophyllum, Kaladana, Jalap and lpomoea are acrid; while Ipecac, Acorus, and Tylophora indica
contain nauseous taste.
• Glycyrrhiza has hard and fibrous fracture due to the presence of fibrous and woody tissues.
• Aconite has a horny fracture due to gelatinization of starch.
Standardization and Determination of colour of drugs:
Colour of drugs are standardized and determined by the Inter-Society Colour Council-National Bureau of
Standard method.
For example, reserpine is described as a "white or pale buff to slightly yellowish, odourless crystalline
powder”.
MICROSCOPICAL AND ANATOMICAL
EVALUATION
• Schleiden (1847) used microscope for the examination of drugs.
• Microscopic examination of section and powder drugs, aided by stains, helps in distinction of
anatomy in adulterants.
• Further, microscopical examination of epidermal trichomes and calcium oxalate crystals is
extremely valuable, especially in powdered drugs.
• In the powdered drugs the cells are mostly broken, except lignified cells.
• The cell contents such as starch, calcium oxalate crystals, aleurone, etc. are scattered in the
powder. Some fragments are specific for each powder which may consist of parts of cells or
groups of cells.
• Plant parts are made up of specific arranged tissues, spores (Lycopodlum) or hairs (Lupulin).
• Histological characters are studied from very thin transverse, or longitudinal sections properly
mounted in suitable stains, reagents or mounting media.
• The size, shape and relative positions of the different cells and tissues, chemical nature of the
cell walls and of the cell contents are determined.
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• The basic arrangement of tissues in each drug is fairly constant.
• Fibres, sclereids. tracheids, vessels and cork are least affected by drying.
• Starch, calcium oxalate, epidermal trichomes and lignin are examined carefully.
• Microscope is also used for a quantitative evaluation of drugs and adulterated powders.
• This is done by counting a specific histological feature such as stomatal index, veinislets and vein
termination numbers, palisade ratio. etc.
• These features are compared with the standard samples.
Palisade Ratio :
• The average number of palisade cells beneath each epidermal cell Is called as palisade ratio.
• It is determined from powdered drugs with the help of camera lucida.
Stomatal Number :
• The average number of stomata per square millimeter of the epidermis Is known as stomatal
number.
• The range and average value for each surface are recorded.
Stomatal Index :
• The percentage proportion of the number of stomata form to the total number of epidermal
cells of a leaf is termed the stomatal index
S.I. = S/E+S x 100
• where S = number of stomata per unit area, E = number of ordinary epidermal cells In the same
• unit area. Stomatal number varies considerably with the age of the leaf but the stomatal index is
highly constant for a given species.
Vein-Islet Number:
• The word 'Vein-islet' is used for the minute area of photosynthetic tissue encircled by the
ultimate divisions of the conducting strands. Vein-islet number is defined as the number of vein-
islets per square mm calculated from four contiguous square mm In the central part of the
lamina, midway between the midrib and the margin. The average range of vein-islet numbers,
for Senna are : Cassia senna (26), C. angustifolta (21): for Coca: Erythroxylum coca (11), E.
truxillense (20); for Digitalis.
• Digitalis purpurea (3.5) D. lanata (2.7); D. Lutea (4.4), D. thapsi (1.2).
Veinlet Termination Number :
• It is defined as the number of veinlet terminations per mm2 of leaf surface.
• A vein termination is the ultimate free termination of a veinlet or branch of a veinlet.
• By this character different Coca leaves and Senna leaflets are differentiated.
LYCOPODIUM SPORE METHOD:
Lycopodium Spores
Biological Source: Lycopodium clavatum
Family: Lycopodiaceae
Part Used: spores of the clubmoss.
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Synonym: Club-moss spores, Lycopodium seeds, vegetable sulphur
Habitat: Grows in the North America, Russia, Poland. India and Pakistan.
Collection: The sporangial spikes are cut and dried and the spores are separated by shaking.
Physical Characterictics: Lycopodium is a light yellow, extremely mobile and flammable powder without
odour or taste.
Constiteunts: It contains about 50% fixed oil, which consists mainly of glycosides of lycopodiumoleic
acid: sugars (3%), phytosterin and alkaloids of the annotine type.
Lycopodium spores are exceptionally uniform in size (about 25 pm) and 1 mg of lycopodium contains
an average of 94,000 spores.
Evaluation of Drugs by Lycopodium Spore Method:
• The number of spores per milligram is determined by direct counting and by calculation based
on specific gravity and dimensions of the spores.
• It is possible to evaluate many powdered drugs if well-defined particles may be counted as in
case of pollen grains or starch grains; or if single layered tissues or cells of the area of which may
be traced at a definite magnification and the actual area calculated; or if characteristic particles
of a uniform thickness, the length of which can be measured at a definite magnification and the
actual length calculated. Mounts containing a definite proportion of the powder and lycopodium
are used and the lycopodium spores counted in each of the fields in which the number or area
of the particles in the powder is determined.
Procedure:
• In this method the moisture content of the powdered material is determined.
• A mixture of weighed quantity of the powder and lycopodlum spores is suspended In a suitable
viscous liquid.
• A drop of this suspension is mounted and examined with a 4 mm objective.
• The number of lycopoclium spores and the number of characteristic particles are counted in 25
various fields.
• The same experiment is repeated with a second similar suspension.
• From the mean of these results and a knowledge of the weights of lycopodlum and powder in
the mixture, the number of characteristic particles in 1 mg of the powder may be determined.
Examples:
By employing lycopodium spore method the number of pollen grains in,
• pyrethrum powder (1000 2000/mg),
• starch granules in wheat powder (400 granules/mg)
• starch grain in Ginger (261400 grains/mg) have been determined.
Determination of Size by Lycopodium Spore Method:
Lycopodium spore method is also used to determine size of a particular type of particle in powders such
as epidermal fragments of leaves, single layer of scalerenchyma, or isolated fibres.
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Procedure:
• The procedure is almost the same as used for counting of particles.
• The particle size is traced with the help of camera lucida and the spores are counted.
• The tracings are cut out and weighed and their area calculated by weighing a sheet of known
area of the paper used.
• This area divided by the magnification used (420)2 gives the actual area of the particles in a
certain weight of the powdered drug, which is calculated from the number of spores counted
and the weight of spores and powder in the suspension.
Examples:
By this method epidermal area of Indian Senna stalk (100 cm2), sclerenchyma layer in Linseed, fibres In
the Cinnamon bark and number of beaker cells In testa of Cinnamon seed have been measured.
CHEMICAL EVALUATION
Chemical evaluation involves the determination of active constituents by a chemical process.
Chemical Test:
Chemical tests are used to identify certain crude drugs to determine purity.
Chemical tests for alkaloids, carbohydrates, steroids, Phenolic compounds, saponins, proteins, amino
acids, fixed oils and volatile oils are performed.
Titrimetric assay, iodine value, saponification value, acid value, acetyl value, ester value, peroxide value,
hydroxyl value and ash value are determined.
• Tropane alkaloids in Datura, Belladonna and Stramonium are determined by Vitali-Morin
reaction. Potassium chlorate and hydrochloric acid are used to estimate emetine in Ipecac.
• Strychnine in Nux-vomica is detected with ammonium vanadate and sulphuric acid.
• Borntragers test is useful for detecting anthraquinone glycosides, present in Senna, Rhubarb,
Cascara and Aloe.
• Alkaloid contents can be evaluated by determining total alkaloidal contents by acidbase
titration.
Qualitative analysis:
• Qualitative analysis is useful in the detection of adulteration.
• It is used in estimation as Iodine value, saponification value, acid value, ester value, peroxide
value, hydroxyl value.
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Borntrager’s Test:
• Anthraquinone glycosides are detected in Senna, Rhubarb, Cascara and Aloe are identified via
this drug. Powdered drug is macerated with ether or chloroform and it is filtered.
• Add ammonia and Shake.
• Pink, red or violet colour indicates positive for anthraquinone derivatives
Vitali-Morin’s Test:
• Tropane alkaloids in Datura, Belladonna, and Hyoscyamous are determined by Vitali- Morin
Reaction. Add Crude Extract + HNO3 and Evaporate it to dryness.
• Dissolve residue in acetone, add methanolic solution of KOH
• Violet color will give positive test.
Protein Station - Biuret test:
• Put a drug containing protein into a test tubes (i.e. milk or tofu).
• If it is not a liquid, add some water and mash it well.
• Also set up a control, a test tube containing a liquid that does not contain protein (i.e. water).
• Add about 2ml of Biuret reagent to the test tube.
• Show students the positive - purple or pink - test result indicating the presence of protein.
Lipid Station:
Testing for the presence of lipids: Sudan red test
• Add 2ml of any oil and 2ml of water to a test tube.
• Then add 2-5 drops of Sudan red to the mix.
• Shake.
• Then repeat with a test tube containing only water.
• Sudan red with stain the fat molecules.
• The more fat it contains, the more particles the Sudan red will stain.
Testing for the presence of lipids: Grease spot test
• Draw four squares onto their brown paper bag, and then use a cotton swab to put samples of
three lipids of their choice and water as a control into the squares.
• Wipe off excess oil/fat and let sit for few minutes to dry.
• Once dry, the fats will leave a translucent spot behind.
• This can best be seen when you hold the paper up to a light source.
• Put some sesame or sunflower seeds between two pieces of brown paper and press hard.
• The seeds are loaded with oil and will leave behind grease spots.
Carbohydrate station:
Test for monosaccharides: Benedict reagent
• Put 2-3 ml of corn syrup in a test tube.
• Add 1ml of the Benedict Reagent, the solution will look blue.
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• Put the tube in a gently boiling water bath. Wait a few minutes.
• The glucose present in the solution reacts with the copper sulfate in the Benedict reagent and
makes copper oxide that is an orange to red-brick precipitate.
• The intensity of the color depends on the concentration of glucose present in the sample.
Test for Starch (Polysaccharide): Iodine solution
• Put 2-3 ml of starch solution in a test tube
• Add 3-4 drops of iodine
• A bluish black color indicates a positive test for starch.
Trimetric Assay:
These are titrimetric Assays in which the potency of the chief constituent is determined.
In chemical assays chief constituent of drugs are extracted by suitable solvent, and then purified.
These chief constituents are assayed, purified and its potential values such as,
• Iodine Value
• Saponification value
• Acid Value
• Peroxide value
• Acetyl value
Iodine Value:
A measure of the iodine absorbed in a given time by a chemically unsaturated material, such as oil;
used to measure the unsaturation of a compound or mixture.
Also known as iodine number (indicates the ease of oxidation or the drying capacity of the product).
Saponification Value:
Saponification is the hydrolysis of an ester under basic conditions to form an alcohol and the salt of a
carboxylic acid.
Saponification value represents “the number of milligrams of potassium hydroxide or sodium
hydroxide required to saponify 1g of fat under the conditions specified.”
Acid Value:
A measure of the amount of free acid present in a fat, equal to the number of milligrams of potassium
hydroxide needed to neutralize this.
Peroxide value:
The peroxide value is defined as the amount of peroxide oxygen per 1 kilogram of fat or oil.
Acetyl value:
The milligram of KOH required neutralizing the acetic acid produced by the hydrolysis of 1 g of
acetylated fat; (a measure of the hydroxy acids present in glycerides).
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Quantitative analysis
• Quantitative analysis is also the part of chemical evaluations.
• Purity of crude drug is determined by quantitative analysis.
• Chemical analysis also covers the phytochemical screening carried out to establish the chemical
profile. Sublimation, Fractional distillation, steam distillation
PHYSICAL EVALUATION
Introduction:
• It is rarely used for crude drugs.
• Physical contents such as elasticity in fibres, viscosity of drugs containing gums, selling factor for
mucilage containing materials, froth number of saponin drugs, congealing point of volatile and
fixed oils, melting and boiling points and water contents are some important parameters used in
the evaluation of drugs.
• Ultraviolet light is also used for determing the fluorescence of extracts, powdered or thin layer
of some drugs.
➢ Aconite-----light blue
➢ Emetine-----orange
➢ Berberine----yellow
• Froth number for saponins
• Congealing point for volatile/fixed oils
Physical Constant:
Physical constants are extensively applied to the active principles of drugs, such as alkaloids, volatile oils,
fixed oils etc.
A few of them are:
➢ Moisture Content
➢ Viscosity
➢ Melting point
➢ Optical Ratation
➢ Refractive Index
➢ Ash Content
➢ Extractive values
➢ Volatile oil Content
➢ Rf Values
➢ Solubility
➢ Foreign Organic Matter
➢ Swelling Factor
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1.Solubility:
• We should determine solubility of a drug in different solvents.
• The presence of adulterant in a drug could be indicated by solubility studies.
• Usually it is expressed in the following form:
• 1g is soluble in ….ml of water, … ml of alcohol, etc.
• For example; Castor oil is soluble in 3vol of 90% alcohol while adulterated form show good
solubility in alcohol.
2.Specific Gravity:
• Specific gravity is determined particularly of the fats and volatile oils.
• Weight of a given volume of liquid compared with the weight of equal volume of water at
specific temperature and pressure in air is called as specific gravity.
• The specific gravity of anise oil is not less than 0.978 and not more than 0.988.
• Specific gravity of water =1
• Most of volatile oil is lighter than water, except V.O. of clove
• Cinnamon (heavier than water)
3.Optical Rotation:
• Optical activity is the ability of a chiral molecule to rotate the plane of planepolarized light.
• Dextro (+) rotary: rotate plane of polarized light to right (clock wise)
• Levo (-) rotary: Rotate plane of polarized light to left (anti-clock wise)
• Certain substances are found to have the property of rotating the plane of polarized light.
• Normally, it is determined at 25°C using Na-lamp as the source of light.
It is measured by polarimeter.
➢ Autonomic Digital Polarimeter: Its range is ±45◦ . Polarimeter cell is 100mm, 200 mm and has a
sodium lamp.
➢ Hand-Held Polarimeter: Wavelength of 589 mm, measurement range is - 35◦ to +35◦ .
Example:
No. Drugs Angles of Optical Rotation
1 Caraway Oil ₊75◦ to ₊80◦
2 Clove Oil 0◦ to ₊6.0◦
3 Honey ₊3◦ to ₋15◦
4 Atropine ₊0◦
4.Refractive Index:
• It is determined particularly for the fixed and volatile oils (crystals, liquids).
• It is a ratio of sign angle of incidence/sign angle of refraction of monochromatic beam.
• RI is measured by refractometer.
• It is constant for a liquid and can be considered as one of the criteria for its standardization.
• For example; the RI of peppermint oil is not less than 1.4590 and not more than 1.4650 at 20 ◦C.
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5. Congealing Point:
• It is particularly of fixed and volatile oils.
• The solidification range of fatty acids in olive oil is between 17 and 26◦C.
6. Melting Point
• It is of extreme importance, there is a constant range of M.P. using specific solvent.
• In case of pure chemicals or phytochemicals M.P. are sharp and constant.
For example;
No. Drugs Melting Point (◦C)
1 Colophony 75-85
2 Bees Wax 62-65
3 Wool Fat 34-44
4 Cocaine 96-98
7.Moisture Content
• Presence of moisture in a crude drug can also lead to its deterioration due to either activation of
certain enzymes or growth of microbes.
• Moisture content can be determined by heating the drug at 150◦C in an oven to a constant
weight and calculating the loss of weight.
No. Drugs Moisture Content W/W
1 Aloe Not more than 10
2 Digitalis Not more than 5
3 Starch Not more than 15
8.Viscosity
• Viscosity of a liquid is constant at a given temperature and is an index of composition.
• Hence, it is used as a means of standardizing liquid drugs.
For example:
Liquid paraffin – kinematic viscosity not less than 64-centistokes at 37.8◦
Pyroxylin – kinematic viscosity, 1100-2450 centistokes.
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9.Foreign Organic Material
• It is the part of organ or organs other than those named in the definition and description of the
drug are defined as foreign matter.
• The maximum limit is defined in monograph (a detailed written study of a single specialized
subject or an aspect of it).
• If it exceeds the limits, deterioration in quality of the drug takes place.
• The physical or chemical parameters useful in quality profile of a crude drug evaluation.
BIOLOGICAL EVALUATION
The drugs, which cannot be assayed satisfactorily by chemical or physical means, are evaluated by
biological methods.
Tests are carried out on intact animals, animal preparations, isolated living tissues or micro-organisms.
Since living organisms are used, the assays are called 'biological assays'.
Biological standardization procedures are generally less precise, more time consuming and more
expensive to conduct than chemical assays.
Therefore, they are generally used if the chemical identity of the active principle has not been fully
elucidated: if, no adequate chemical assay has been derived for the active principle as in case of insulin:
if the drug is composed of complex mixture and activity , e.g. Digitalis: if the purification of crude drug is
not possible, e.g. separation of vitamin D from irridiated oils: and if the chemical assay is not a valid
indication of biological activity.
Biological Assay:
• A biological assay measures the actual biological activity of a given sample. In any one test the
animals of only one strain are used.
• For some assays a specific sex must be used.
• The male rat has faster growth rate than the female.
• Therefore, use of both male and female in a growth test should be avoided.
• Bioassays are conducted by determining the amount of a solution of unknown potency required
to
• produce a definite effect on suitable test animals or organs under standard conditions.
• To minimize the source of errors resulting from animal variation, standard reference
preparations are used in certain bioassay procedures.
Organsims Used:
• In past living organisms like yeast, molds, bacteria and virus were used.
• Now most of the microbiological assays of vitamins except vit.B12 and calcium has replaced by:
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Spectrophotometry assays (Spectrophotometer is a machine used to measure the amount of
light a substance's absorbs, to combine kinetic measurements and Beer's law by calculating the
appearance of product or disappearance of substrate concentrations).
Fluorometric assay (Fluorescence is when a molecule emits light of one wavelength after
absorbing light of a different wavelength. Fluorometric assays use a difference in the
fluorescence of substrate from product to measure the enzyme reaction).
• Antibiotic activity measurement
• Cylinder-plate(or cup plate) method
• Turbidity method
1.Bacteria:
For evaluation of phenol content(disinfectants) or antiseptic value e.g. S. typhi, S. aureus.
2.Mice:
It is used as a test animals in the safety for rabies vaccines, diptheria toxoid and other biologicals.
Rats are used in the assay of vassopressin.
3.Chicks:
Oxytocic injection is assayed on young domestic chickens by injecting into an exposed crural or brachial
vein and observing changes in blood pressure.
4.Pigeons:
Digitalis glycosides are assayed on pigeons by transfusing the drug through the alar vein into the blood
stream and noting the lethal effects.
5.Cats:
Drugs with depressor activity and glucagon are tested upon cats. And to find Mydriatic drugs e.g.
atropine.
6.Rabbits:
Ophthalmic preparations on rabbit eye are assayed.
7.Dogs:
For depressor activity test and to assay veratrum viride preparation.
8.Earth worms:
For Anthelmintic drugs
9.Human beings:
Only used at clinical trial.
Disadvantages of Bioassays:
• Less quantitative accuracy
• Human/technical variation
• Difference in effect from human data.
Bioassay utilizing brine shrimp:
• A simple bioassay utilizing brine shrimp (Artemia sauna) is available for determining new
biological activities in plant extracts.
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• The eggs of this creature, which serve as food for tropical fish, are allowed to hatch in a brine
solution.
• Its shrimp are exposed to different conceptrations of the test material and an LC (median lethan
concentration) value in tg/ml is calculated.
• A broad range of compound show toxic effect to the shrimp.
• The procedure is rapid, reliable and cheap.
• Another procedure, called potato-disc assay, involved observation of the Inhibition of crown gall
tumors induced on, potato discs by Agrobacteriu.m tumefaciens by plant extracts or isolated
compounds.
• This method is used for detecting In preliminary fashion anticancer activity.
DRUG ADULTERATION
Definition:
The term adulteration is defined as substituting original crude drug partially or wholly with other similar-
looking substances. The substance, which is mixed, is free from or inferior in chemical and therapeutic
property.
Adulteration is the practice of substituting original crude drug partially or whole with other similar
looking substances but the later is either free from or inferior in chemical and therapeutic properties
Example:
- Loss of caffeine by over roasting of coffee beans.
- Hardening of powdered squill due to absorption of moisture.
- Ergot contaminated by mold or any drug infested by insects.
Adulterant:
A substance added to a product but not listed as an ingredient, or a substance that ends up in a
product by accident when the product is made. Adulterants may be in foods, drugs, and other
products.
Types of Adulterants:
Adulteration in simple terms is debasement of an article.
The motives for intentional adulteration are normally commercial and are originated mainly with the
intension of enhancement of profits.
Some of the reasons that can be cited here are scarcity of drug and its high price prevailing in market.
The adulteration is done deliberately, but it may occur accidentally in some cases. Adulteration involves
different conditions such as deterioration, admixture, sophistication, substitution, inferiority and
spoilage.
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Reasons for Adulterations:
• Scarcity of the drug
• The high price of the drug in the market
• It is very common with contraband drugs e.g; Opium, Mehtemphetamine .
Types of Adulteraion:
• Inferiority
• Spoilage
• Admixture
• Substitution
• Deteriotion
• Sophistication
• True Adulteration
1. Inferiority
• It refers to a substandard drug or any other substance regardless to the cost. Any
substandard drug produce naturally.
• Example: Dried seeds of Nux-vomica containing less than 1.15% strychnine would be of
inferior quality and substandard drug.
2. Spoilage
• It is a condition of a food or a drug (crude) in which quality of the usefulness of the materials
has been destroyed by fungus or bacteria or molds to such an extent that it is not fit for
human use such drugs are legally considered as adulterated drugs.
3. Admixture
• Addition of one material to another either accidently or carelessly or ignorance. If done
intentionally then considered adulteration and specifically admixture.
• Example: Addition of rodent feed matter into cardamom seeds.
4. Substitution
• It can be defined as complete replacement of one article with another article, is referred to
as substitution.
• Example: Replacement of fructose with glucose is a substitution adulteration.
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5. Deterioration
• It means any impairment of quality either by removing (abduction) or by destruction of valuable
constituents by different means e.g. distillation, fungus, insects, heat, moisture, aging etc.
6. Sophistication
• Addition of inferior material to another article with a definite intention of fraud, is referred to as
sophistication.
• Example: Addition of wheat flour to ginger powder.
Methods of Adulteration:
Unintentional Adulteration:
Unintentional adulteration may be due to the following reasons:
• confusion in vernacular names between indigenous systems of medicine and local dialects
• lack of knowledge about the authentic plant
• nonavailability of the authentic plant
• similarity in morphology and or aroma
• careless collection
• other unknown reasons
Name Confusion:
In ayurveda, ‘Parpatta’ refers to Fumaria parviflora. In siddha, ‘Parpadagam’ refers to Mollugo
pentaphylla. Owing to the similarity in the names in traditional systems of medicine, these two herbs are
often interchanged or adulterated or substituted. Because of the popularity of siddha medicine
in some parts of south India, traders in these regions supply M. pentaphylla as Parpatta/Parpadagam
and the north Indian suppliers supply F. parviflora.
Lack of knowledge about authentic source:
‘Nagakesar’ is one of the important drugs in ayurveda. The authentic source is Mesua ferrea. However,
market samples are adulterated with flowers of Calophyllum inophyllum. Though the authentic plant is
available in plenty throughout the Western Ghats and parts of the Himalayas, suppliers are
unaware of it. There may also be some restrictions in forest collection. Due to these reasons,
C. inophyllum (which is in the plains) is sold as Nagakesar. Authentic flowers can be easily identified by
the presence of two-celled ovary, whereas in case of spurious flowers they are single celled.
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Similarity in morphology:
Mucuna pruriens is the best example for unknown authentic plant and similarity in morphology. It is
adulterated with other similar papilionaceae seeds. M. utilis (sold as white variety) and M. deeringiana
(sold as bigger variety) are popular adulterants.
Lack of authentic plant
Hypericum perforatum is cultivated and sold in European markets. In India, availability of this species is
very limited. However, the abundant Indo-Nepal species H. patulum is sold in the name of H.
perforatum. Market sample is a whole plant with flowers, and it is easy to identify them taxonomically.
Similarity in colour:
It is well known that in course of time, drug materials get changed to or substituted with other plant
species. Ratanjot is a recent-day example. On discussion with suppliers and nontimer forest product
(NTFP) contractors, it came to be known that in the past, roots of Ventilago madraspatana were
collected from Western Ghats, as the only source of ‘Ratanjot’. However, that is not the practice now. It
is clearly known that Arnebia euchroma var euchroma is the present source. Similarity in yielding a red
dye, A. euchroma substitutes V. madraspatana. The description to identify these two is unnecessary
because of the absence of V. madraspatana in market. Whatever is available in the market, in the name
of Ratanjot, was originated from A. euchroma.
Careless collections:
Some of the herbal adulterations are due to the carelessness of herbal collectors and suppliers. Parmelia
perlata is used in ayurveda, unani and siddha. It is also used as grocery. Market samples showed it to be
admixed with other species (P. perforata and P. cirrhata). Sometimes, Usnea sp. is also mixed with them.
Authentic plants can be identified by their thallus nature.
Unknown reasons:
‘Vidari’ is another example of unknown authentic plant. It is an important ayurvedic plant used
extensively. Its authentic source is Pueraria tuberosa, and its substitute is Ipomoea digitata. However,
market samples are not derived from these two. It is interesting to know that an endangered
gymnosperm Cycas circinalis is sold in plenty as Vidari. The adulterated materials originated from Kerala,
India. Although both the authentic plant and its substitute are available in plenty throughout India, how
C. circinalis became a major source for this drug is unknown. P. tuberosa can be easily identified by the
presence of papery flake-like tubers, I. digitata by the presence of its concentric rings of vascular
bundles and their adulterant C. circinalis by its leaf scars and absence of vessel elements.
Intentional Adulteration
Intentional adulteration may be due to the following reasons:
• adulteration using manufactured substances
• substitution using inferior commercial varieties
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• substitution using exhausted drugs
• substitution of superficially similar inferior natural substances
• adulteration using the vegetative part of the same plant
• addition of toxic materials
• adulteration of powders
• addition of synthetic principles
Adulteration using manufactured substances
In this type of adulteration the original substances are adulterated by the materials that are artificially
manufactured. The materials are prepared in a way that their general form and appearance resemble
with various drugs. Few examples; are cargo of ergot from Portugal was adulterated with small masses
of flour dough moulded to the correct size and shape and coloured, first using red ink, and then into
writing ink. Bass-wood is cut exactly the required shape of nutmegs and used to adulterate nutmegs.
Compressed chicory is used in place of coffee berries. Paraffin wax is coloured yellow and is been
substituted for beeswax, and artificial invert sugar is used in place of honey.
Substitution using inferior commercial varieties
In this type, the original drugs are substituted using inferior quality drugs that may be similar in
morphological characters, chemical constituents or therapeutic activity. For example hog gum or hog
tragacanth for tragacanth gum, mangosteen fruits for bael fruits, Arabian senna, obovate senna and
Provence senna are used to adulterate senna, ginger being adulterated with Cochin, African and
Japanese ginger. Capsicum annuum fruits and Japanese chillies are used for fruits of C. minimum.
Substitution using exhausted drugs
In this type of substitution the active medicaments of the main drugs are extracted out and are used
again. This could be done for the commodities that would retain its shape and appearance even after
extraction, or the appearance and taste could be made to the required state by adding colouring or
flavouring agents. This technique is frequently adopted for the drugs containing volatile oils, such as:
clove, fennel etc. After extraction, saffron and red rose petals are recoloured by artificial dyes. Another
example is balsam of tolu that does not contain cinnamic acid. The bitterness of exhausted gentian is
restored by adding aloes.
Substitution of superficially similar inferior natural substances
The substituents used may be morphologically similar but will not be having any relation to the genuine
article in their constituents or therapeutic activity. Ailanthus leaves are substituted for belladona, senna,
etc. saffron admixed with saff flower; peach kernels and apricot kernels for almonds; clove stalks and
mother cloves with cloves; peach kernel oil used for olive oil; chestnut leaves for hamamelis leaves and
Japan wax for beeswax are few examples for this type of adulteration.
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Adulteration using the vegetative part of the same plant
The presence of vegetative parts of the same plant with the drug in excessive amount is also an
adulteration. For example, epiphytes, such as mosses, liverworts and lichens that grow over the barks
also may occur in unusual amounts with the drugs, e.g. cascara or cinchona. Excessive amount of stems
in drugs like lobelia, stramonium, hamamelis leaves, etc. are few example for this type of adulteration.
Addition of toxic materials
In this type of adulteration the materials used for adulteration would be toxic in nature. A big mass of
stone was found in the centre of a bale of liquorice root. Limestone pieces with asafetida, lead shot in
opium, amber-coloured glass pieces in colophony, barium sulphate to silvergrain cochineal and
manganese dioxide to blackgrain cochineal, are few examples in this adulteration.
Adulteration of powders
Powdered drugs are found to be adulterated very frequently. Adulterants used are generally powdered
waste products of a suitable colour and density. Powdered olive stones for powdered gentian, liquorice
or pepper; brick powder for barks; red sanders wood to chillies; dextrin for powdered ipecacuanha, are
few adulterants.
Addition of synthetic principles
Synthetic pharmaceutical principles are used for market and therapeutic value. Citral is added to lemon
oil, whereas benzyl benzoate is added to balsam of Peru. Apart from these, the herbal products labelled
to improve sexual performance in men, when analysed, contained sildenafil.
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UNIT : 5
DRUGS OF ANIMAL ORIGIN
1.SHELLAC
It is a resinous protective secretion of the tiny lac insect .
Common name: Lac
Zoological origin: Laccifer lacca
Family: Laccidae
Habitat: It is produced in Sri lanka, Thailand, China, Vietnam, Indonesia, Mayala, Pakistan.
Description:
• The pest occur both on wild and cultivated plants.
• Red colored larvae of the insect settle on the young fleshy shoots of the host plant.
• With their proboscis suck nutrients from the sap. Insect secrets the thick resinous fluid which envelops
their bodies.
• Secretions from their individual insect coalesce and form a hard continuous envelop over the twig.
• After the completion of life cycle and at the time of next generation emergence the twigs are harvested.
The encrustations scrapped off, dried and further processed to produce the lac.
• This crude lac is called stick lac and is not used in industry.
• Purification Stick lac is powdered and coloring matter is extracted with water or dilute soda solution.
• The solution evaporated to dryness constitutes lac dye.
• And the exhausted lac when dried is called as seed lac.
Types of Seed Lac:
From this seed lac four types of shellac recognized by EP/BP are produced as follows;
Types Preparation Characters
Wax containing shellac Seedlac →filteration through bags
or by hot solvent extraction On
cooling subjected to stretching into
long sheets and then broken
Flakes Bownish-orange or yellow
Insoluble in water, partly soluble in
ether and with alcohol gives an
opalescent solution.
Bleached shellac Seedlac is dissolved in hot soda
solution, bleached with
hypochlorite or chlorine and ppt. by
acid. It is pulled under water into
sticks and dried.
Cream-brownish-yellow powder.
Opalescent solution formed with
alcohol.
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Dewaxed shellac Seedlac or wax-containing shellac
by treatment with a suitable
solvent and removal of the wax by
filtration.
Flakes Gives clear solution with
alcohol
Bleached Dewaxed shellac Seedlac /wax containing shellac →
treated with soda lime →bleached
(hypochlorite)→Insoluble wax
removed by filteration and product
is ppt. from soln. with dil. Acid and
dried
Bleached shellac Gives clear
solution with alcohol
Commercial grades:
Commercial grades are;
• button-lac
• orange shellac
• ruby or garnet shellac.
Physical properties:
• Yellowish transparent sheet or powder.
• Characteristic odor.
• Soluble in 80-85%alcohol, ether, benzene, petroleum ether and insoluble in water.
Chemical composition:
Lac contains;
• 70-80% resin
• sugars
• proteins
• coloring matter 1-2%,
• wax 4-6%,
• extraneous matter 8-12% and
• traces of volatile oils.
Lac resin contains;
• Hydroxyl fatty acids derivatives (Aleuritic acid) and
• a sesquiterpenes (cedrene type).
Uses:
• Pharmaceutically used in mfg. of sustained release dosage form .
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• Industrially used in the preparation of photographic records, in lacquers and varnishes, in electrical
machines as sealing wax, in inks.
2. MUSK
Common name: Moschus, Kasturi
Biological origin: Moschus moschiferus
Family: Cervidae
Part used: Dried secretion obtained from the preputial follicles of musk-dear.
Habitat: The animal is found in the mountains of regions of Himalayas and in china. It is also reported in
Russia.
Preparation of Musk:
• Musk deer (50cm in height) is contained in an oval hairy projecting sac found only in male,
situated between the umbilicus and the prepuce.
• The sac is known as POD.
• Its weight is 30g and contains half of its weight musk.
• To obtain the perfume from the musk, animal is killed and the gland is completely removed and
dried.
• Either in the sun or by immersion in hot oil.
• It appears in commerce either as MUSK IN POD or as MUSK IN GRAIN.
• The musk in pod have their entire gland.
• Musk in grain is the one in which perfume has been extracted from its receptacles.
Physical properties:
• It is a viscid mass-coarse powder dark brown –brownish red in color.
• It possess very strong characteristic odor and slightly bitter in taste.
• It dissolves in boiling water.
Chemical constituents:
• On distillation, it yields 1.5% w/w of dark brown volatile oil.
• The organic compound responsible for the odor of musk is muskone which is a cyclic ketone
having closed chain of C atoms.
• It also contains fat, wax, cholsterin, albuminoids, ammonia, cholesterin and resins.
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Varieties of musk:
There are three kinds of musk
• Tong-king, Chinese or Tibetan musk: It is the most valued musk and imported from china.
• Assam or Nepal: Slightly lesser in value.
• Karbadin or Russian: Imported from central Asia by way of Russia.
Uses:
• Used as a powerful stimulant in the treatment of hysteria.
• Due to its ability to retain its odor even if diluted upto 3000 times, it is used in perfume industry.
3.CIVET
Introduction:
It is odorus secretion obtained from highly specialized scent glands in the region of external generative
organs of male and female civet cat.
Common name: Zibeth, khatas, Large Indian Civet.
Biological origin: Viverra zibetha
Family: Viverridae
Geographical source:
These cats are found all over South East Asia, Africa, Madagascar and Southern Europe.
Civets are omnivorous (distinguishing characters from other cats).
Physical properties:
Semi liquid, pale yellow in color, obnoxious odor but when diluted becomes very pleasant.
Bitter in taste.
Partially soluble in hot alcohol, ether but insoluble in water.
Chemical constituents:
• It mainly contains civetone, civetol, indole, ethylamine, propylamine and few unidentified free
acids. Civetol is odourless and is converted into cinvetone by chromic acid oxidation.
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Uses:
• Used as flavoring agents in cosmetics and foods and fixative in perfumery.
4. Ambergris
Common name: Grey amber, Amber grease
Biological origin: Physeter catodon
Family: Physeteradae
Geographical source: It is found floating in tropical seas or near sea shores.
Formation:
• It is pathological product formed in intestinal tract of sperm whale.
• The sperm whales feed on squid or cuttle fish.
• The indigestible beaks of these animals cause irritation of whale’s stomach and in turn
stimulates the formation of ambergris.
• Sometimes the masses weighing 1kg – 10kg or more are found at a time.
Physical properties:
• Grey to black waxy mass.
• Agreeable, characteristic, persistent odor.
• It is brittle, flammable and completely volatile by heat (at 100°C as white vapors).
• It is insoluble in water and in alkali hydroxides but soluble in hot alcohol, chloroform, ether, fats
and volatile oils.
Chemical constituents:
It contains triterpene alcohol, amberen (25%) which is white and crystalline emicoprostalol and
coprostanone.
Uses:
• Used in perfumery
• Used for the fixation of delicate flavours as it increases the life of into which it is incorporated.
• It is usually added in lotions
• It is also used to flavor the tobacco.
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• In dose 100mg-800mg it produce significant potentiation of pentobarbitone induced hypnosis,
mild analgesia and anti-convulsant activities.
• When applied externally, removes localized pain, and itching.
• Useful in scabies, pimples and other infection diseases.
5. Cantharides
Zoological origin:
Old name: Cantharis vesicatoria
New name: Lytta vesicatoria
Family: Meloidae
Part used: Dried insects
Habitat: These insects are found on plants of family Caprifoliaceae and Oleaceae. The plants are found
in Central Europe.
Zoological features:
Insects are oblong in shape, brilliant green in color.
Odor is strong and taste is pungent.
Collection:
• They are collected in the month of June and July.
• They are killed by exposing them by the fumes of ammonia or chloroform or carbon disulfide or
by sulpher dioxide.
• Finally they are dried in an oven at temperature not exceeding 40◦C.
• They are packed in air tight containers.
• A few drops of carbon tetrachloride is added as preservative.
Constituents:
• The main constituent is Cantharidin.
• Among the others are uric acid, formic acid, acetic acid, and 12% fats.
Medicinal uses:
• It is used as counter irritant.
• It is used as pustulant.
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• It is used as vesicant.
• It is used as rubefacient.
6. Honey
Honey is a viscid and sweet secretion stored in the honey comb by various species of bees.
Common name: Madh, Mel, Madhu
Botanical origin: Apis dorsota, Apis florea, Apis indica, Apis mellifica
Family: Apideae
Geographical Source: Honey is available in abundance in Africa, India, Jamaica, Australia, California,
Chili, Great Britain and New Zealand.
Preparation and Collection:
• Generally, honey bees are matched with social insects that reside in colonies and produce honey
and bee wax.
• Every colony essentially has one "queen" or "mother bee" under whose command a large no of
"employees" exist which could be sterile females and in certain season’s male bees.
• The employees are entrusted to collect nectar from sweet smelling flowers from far and near
that mostly contains aqueous soln. of sucrose (i.e. approximately 25% sucrose and 75% water)
and pollens. Invertase, an enzyme present in the saliva converts the nectar into the sugar, which
is partly consumed by the bee for its survival and the balance is carefully stored into the
honeycomb.
• With the passage of time the water gets evaporated thereby producing honey (i.e.
approximately 80% invert sugar and 20% water).
• As soon as the cell is filled up completely, the bees seal it with the wax to preserve it for off
season utility.
• The honey is collected by removing the wax wax-seal by the help of a sterilized sharp knife.
• The pure honey is obtained by centrifugation and filtering through a moistened cheese cloth.
• Invariably, the professional honey, and warm the separated combs to recover the bees wax.
Chemical Constituents:
The average composition of honey ranges as follows;
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Moisture 14-24%
Dextrose 23-36%
Levulose (fructose) 30-47%
Sucrose 0.4-6%
Dextrin and gums 0-7%
Ash 0.1-0.8%.
Besides, it is found to contain small amounts of essential oils, bees wax, pollen grains, formic acid, acetic
acid, succinic acid, maltose, dextrin, coloring pigments, vitamins and an admixture of enzymes e.g.
diastase, invertase and inulase.
Interestingly, the sugar contents in honey varies widely from one country to another as it is exclusively
governed by the source of nectar.
Substituents and Adulterants:
• Due to relatively high price of pure honey, it is invariably adulterated either with artificial invert
sugar or simply with cane sugar syrup.
• These adulterants or cheaper substituents not only alter the optical property of honey but also
its natural aroma and fragrance.
Uses:
• It is used as sweetening agent in confectionaries.
• Being a demulcent, it helps to relieve dryness and is, therefore recommended for coughs, colds,
sore throats and constipation.
• Because of its natural content of easily assimiable simple sugars, it is globally employed as a
good source of nutrient for infants, elderly persons and convalescing patients
7.Cod liver oil
Introduction:
It is the partially destearinated fixed oil obtained from the fresh livers.
Types:
It is of two types
Type A
Additional has anisidine value is performed to check the secondary oxidation of oil
Type B
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Commercial product
Cod liver oil was exported from Norway during the middle ages but it was used for non-medical purpose.
In 1752 – 1784, Dr. Samuel Kay introduce it as a medicine. Initially it was prepared by rotting process. In
this method, livers was rotted in barrels and the rising oil to the surface was skimmed. The Modern
process includes – Steaming.
Biological source: Gadus morrhua
Family: Gadidae
Part Used: Partially destearinated fixed oil from fresh livers.
Geographical Sources:
Cod fish inhabit the northern Atlantic Ocean, coming to its shores to spawn in the late winter and spring.
Physical Properties:
• Appearance: Cod liver oil is a thin oily liquid.
• Odor: It has a peculiar, slightly fishy but not rancid odor.
• Taste: Fishy taste
• Solubility: It is slightly soluble in alcohol but freely soluble in ether, chloroform and ethyl
acetate.
Oil Preparation:
A.Collection and extraction:
• Cod livers contain 50% oil, removed immediately as the fishes are boarded and transferred to
steamers in which the oil is released from tissues.
• Crude oil is separated and stored at low temperature.
B.Preparation:
The principal stages in the preparation of medicinal oil are
1.Refining of crude oil
• It improves the quality and flavor.
• It is carried out in air free conditions.
• It is carried out In UK in continuous, automatic, hermetic refining plants Heating of crude oil to
77◦C in heat exchanger.
• Passed through the dics type mixers+ addition of reagents (impurity removal + small liver tissue
dissolution) .
• Oil and water are removed in hermetic separator in air free environment .
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• The process is repeated in mixers and separators In third stage same apparatus is used to water
wash the oil .
2.Drying
• Carried out in vaccum drying tower which continuously evaporates the even small amount of
water and discharges a clear, bright, highly refined oil.
• 50-60 tons of oil per day .
3.Winterization
• Medicinal and veterinary oils are cooled to 0◦C.
• Stearin separates
• Removal of solid by cold filtration
4.Decolorization
• Carried out in steam in vacuum which removes 0.02% of aldehydic and ketonic impurities
5.Standardization for Vit. Content
BP oil 1g – 600units of Vit. A and 60 Units of D
Constituents:
• The oil contains Vitamin A and Vitamin D.
• The oil consists of glyceryl esters of unsaturated (oleic, linoleic, gadoleic and palmitoleic)
• Saturated (myristic,palmitic and traces of stearic) fatty acids.
Uses:
• It is used for the cure n prevention of rickets.
• Cod liver oil is employed for its content of antixerophthalmic and antirachitic vitamins.
• Due to Vitamin A it is valuable as a “flesh builder” in wasting diseases and as a “growth
promoter” in children.
• Due to Vitamin D it helps to utilize calcium in the formation of bones and teeth.
8.Spermaceti
Common name: Sperm whale
Biological origin: Physeter macrocephalus
Family: Physeteridae
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Part used: Waxy substance obtained from head cavity of sperm whale.
Whaling has let the sperm whale as endangered species. So, natural spermaceti is no longer been used
synthetic spermaceti and jojoba oil are used as its substitutes.
Method of obtaining Spermaceti:
• It is obtained from the head of sperm whale.
• After, whaling cavities are formed in the head of sperm whale.
• The waxy substances is then collected from these cavities.
• A large sperm whale contain on average 3 tons of spermacrit.
Constituents:
• It contains mixtures of hexadecyl esters of fatty acids.
• These esters constitute 85% of total weight.
• The major constituents are hexadecyl dodecanoic acid (cetyl lorate), hexadecyl tetradecanoic
acid (cetyl myristate), hexadecyl hexadecanoic acid (cetyl palmitate), hexadecyl octadeconoic
acid (cetyl sterate).
Synthetic spermaceti:
• It is composed of esters of saturated fatty acids (C14 – C18) with saturated fatty alcohol (C14 –
C18).
Uses:
• It is used as ointment base.
• It is used as emollient.
• It is used as stiffening agent in pharmaceutical preparations.
• It is also employed is cosmetics which are topically used in the form of inunction.
9.Gelatin
Biological source: Bos Taurus
Family: Bovidae
Part Used: collagenous tissue like skin,tendons,ligaments and bones
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Preparation:
• Through the process of preparation of gelatin varies in many of the industries.
• Generally the raw material first subjected to the process of liming by placing the material of skin
and tendons in a dilute milk of lime.
• The process of liming dissolves the unwanted materials like the fleshy matter,chondro proteins
and saponified fat present in the connective tissues.
• The skin is then washed with water.
• If the raw material used is bone then it is first grounded and then defatted with any organic
solvent like benzene in an iron cylinders.
• The defatted material is then treated with mineral acid like HCl.
• The treated material is then heated in an open pan or under pressure in perforated false
bottoms.
• The fluid obtained is then evaporated under pressure to get a gelatin concentration of 45-50%.
• The concentrated fluid is then spreaded on glass tray to form a jelly.
• The jelly is removed and passed through wire netting and then dried at various temperature for
a month at an increasing rate of 10◦C each time from 30◦C to 60◦C.Bleaching with sulphur
dioxide is also done to obtain gelatin with lighter color.
Description:
• Gelatin is found in thin sheet form or as powder.
• Its color is yellow to amber and is odorless and tasteless.
• It is hard and brittle in nature.
• It swells in cold water and gets dissolved on heating,also soluble in acetic acid,alcohol and ether
etc.
• It forms glutin,peptone,hydrochloride on boiling with dilute HCl.
Constituents:
• The main constituent is glutin.
Uses:
• It is mainly used in manufacturing of hard and soft capsule shells,for micro encapsulation of
drugs.
• It is used as a vehicle in some injections,in the preparation of bacteriological culture media,as a
base for glycerin suppositories,preparation of pessaries and pastills.
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UNIT : 6
BIOLOGICS
Definition:
“Any product obtained from a living plants or animals is known as biologic. “
According to FDA
“Any virus, therapeutic serum, toxin, antitoxin and their analogue that may be viral vaccine, bacterial
vaccine, immune serum, human blood or products derived from blood used in diagnosis, prevention
and treatment of diseases.”
OR
“A preparation such as drug, vaccine, antitoxin that is synthesized from living organisms or their
products as a diagnostic, preventive and therapeutic agent. “
➢ Biologics have expiry date and storage conditions.
➢ They should be properly labelled with name.
➢ Biologics must have batch number, manufacture license number and storage conditions.
Classifications of biologics:
• Antigen
• Antibody
Antigen:
Any substance that provokes immune system and causes immune response is called antigen.
Categorical definition of antigens:
Biologically: Biologically antigen is any substance or the material that when enters the tissues of
humans or other vertebrates causes production of antibodies.
Biological properties:
Immunogenicity: It has the capacity to induce antibody formation or induce immune response.
Specificity: Antigen is specific to react with specific antibody. Specificity is governed by small chemical
sites on the antigen molecules called antigenic determinants.
Chemically: Antigen are usually proteins however some high molecular polysaccharides are antigenic.
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Physically: Antigen must possess a high molecular weight. A weight of more than 10,000 Dalton is
required.
Hapten:
• Hapten is the incomplete antigen having molecular weight less than 10,000 Dalton.
• It has no ability to produce immune response.
• It combines with host protein and act as antigen.
The simplest form of an antigenic determinant present on a complex antigenic molecule is called an
epitope.
Antibody:
• Any substance that is produced in response to antigen is called antibody.
• Usually antibodies exist in human serum, other secretions and mucous membrane.
• Specialized cells of the immune system can recognize the antigen and are able to set off
complex chain of events designed to kill these foreign invades.
Fractionation of human blood by electrophoresis give following four fractions
• Albumin
• 𝜶 globulin
• 𝜷 globulin
• 𝜸 globulin
Immunoglobulins:
Antibodies that exist in 𝛾 globulin fraction are known as Immunoglobulin.
Classes of immunoglobulin:
1.IgG:
• It constitutes about 80% of the total antibodies.
• Its molecular weight is 1,50,000 Dalton and consists of only 1400 amino acids.
• It occurs in tetrameric form having two identical halves which together form the Y-linked shape.
• Each of the fork contain antigen binding site.
• It is the only class of immunoglobin that can cross placenta.
2. IgM:
• It is also known as material antibody.
• It is the first antibody that is made by fetus and the first immunoglobulin made by virgin B cells
when it is stimulated by antigen.
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• It occurs in pentameric form.
3.IgA (Alpha heavy chain):
• It is predominant immunoglobulin that is found external bodily secretions such as saliva, tears,
GIT fluid, respiratory secretion (my also cause asthma).
4.IgD (Delta heavy chain):
• It is present in lowest concentration primarily found on B cell surface where it functions as a
receptor for antigen.
5.IgE (Epsilon heavy chain):
• It functions in allergic reactions.
• It is a hypersensitivity antibody and bound with mast cell of the surface of tissue.
Immunity
Definition:
“ It is the state of having sufficient biological defense to avoid infection, disease or other unwanted
biological invasion.”
It is the capability of the body to resist harmful microbes from entering it.
Types:
Innate immunity:
• It is the natural resistance with which a person is born.
• It depends upon race, genetic make-up.
• It can never be finished nor be increased .
Acquired Immunity:
The immunity obtained either from the development of antibodies in response to exposure an antigen
as from vaccination or an attack of an infection, disease or from the transmission of antibodies from
mother to fetus through the placenta or the injection of antiserum.
Types of acquired immunity:
• Active immunity (natural or artificial)
• Passive immunity (natural or artificial)
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Active immunity:
▪ It is produced by introducing antigenic substances.
Naturally acquired active immunity:
▪ It is received by the body in natural manner.
▪ It occurs when exposure to antigen is unintentional.
▪ It often follows a disease mumps, measles.
Artificially acquired active immunity:
▪ It is received by the body through the administration of vaccine or toxoid that act as antigen as
exposure to antigen is intentional.
Passive immunity:
▪ It is produced by injecting preformed antibodies from external to the body.
Naturally acquired passive immunity:
▪ It develops when antibodies pass into the fetal circulation from mother blood.
Artificially acquired passive immunity:
▪ It develops from the intentional injection of antibody rich serum into the circulation.
Vaccines
Definition:
Vaccines may contain living, attenuated or killed viruses or bacteria and they are used as inoculations to
stimulate the production of antibodies and provide immunity against one or several diseases.
Primary active immunity from vaccination develops more slowly than the incubation period of most
infections and must be induced prior to exposure to the infectious agent; therefor the general action of
vaccine should be considered prophylactic.
Nonliving vaccines provide protection for only a limited time. Active immunization with living agents is
generally preferable to immunization with killed vaccines because of a superior and more long-lived
immune response. Active immunization may cause fever, malaise and soreness at injection sites.
Use of vaccines is contraindicated under conditions in which the immune response may be depressed
such as during therapy involving corticosteroids, antineoplastic agents, immunosuppressive agents or
radiations in patients with immunoglobulin deficiency and in patients with latent or active infections.
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Viral vaccines
1.Poliomyelitis vaccines:
It is the sterile suspension of inactivated poliomyelitis virus of types 1,2 and 3. Sometimes it is also called
“Salk vaccine”, “Trivalent vaccine” or “Sabin vaccine”.
Polio is the very serious infection that cause paralysis of the muscles that enable the body to walk and
breath.
Types:
▪ Type I (brunhilde) most often isolated from paralysis cases.
▪ Type II (lansing) concerned in sporadic diseases.
▪ Type III (leon) proved to be etiologic agent in less frequent epidemics.
Types of polio vaccines:
• Polio vaccine by injection
• Oral polio vaccine
Discovery:
Landsteiner and Popper in 1908 first transmitted and isolated poliomyelitis virus in monkeys. It was
subsequently ascertained that monkeys that had survived one attack of poliomyelitis were resistant to
further attacks. Furthermore blood serum from such monkeys neutralized the virus in vitro. During 1948
Dr. John F. Enders and his associates originated a method of cultivating polio virus in vitro on animal
tissues other than nervous tissues. Then in 1953 Dr. Jonas Salk and his coworkers perfected the roller-
tissue method of polio virus culture as well as the final detoxified form of polio vaccine.
Preparation:
• The virus strains are grown separately in primary cultures of Rhesus monkey kidney tissues
bathed by a complex nutrient fluid containing more than 60 ingredients.
• After incubation the virus is harvested by decanting the nutrient fluid that is clarified by
filtration and formaldehyde 1:4000 is added.
• The formaldehyde treated virus is maintained at 36◦C at pH 7 until all viruses are killed.
• A series of teste is performed to ascertain that all viruses are inactivated.
• The formaldehyde is neutralized and a preservative is added.
• The 3 types of virus are then pooled and the resultant mixture is the trivalent vaccine.
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Dose:
The usual dose given S/C is 3 injections of 1ml,4 or more weeks apart and the 4 th reinforcing dose of
1ml,6-12 months later.
Oral polio vaccine:
• It was developed by Albert Sabin. It is also known as trivalent oral polio vaccine or Sabin vaccine.
• The amount equal to 1 sugar grain is sufficient to produce immunity.
• 5% dose is given due to active virus.
• It consists of a mixture of live attenuated polio virus strains of all three polio virus types.
Advantages:
• Ease of administration.
• Low cast and long-lasting immunity
• Can also be used when polio virus has formed colonies in the intestine.
Storage:
It is stored at -10◦C.
2.Yellow fever vaccine
• The vaccine is used to treat yellow fever (yellow jack), black vomit.
• It is a serious disease that is caused by yellow fever virus called Flavi.
• Fibricus is the causative agent and its vector is Aedes mosquito.
Effects of fibricus:
• Fever and flue.
• Jaundice
• Liver, kidney and respiratory failure.
• Death
Preparation:
• Live attenuated stains of yellow fever virus are grown on the tissues of domestic fowl Gallus
domesticus.
• Virus is inoculated to its embryo and after sufficient growth suspended in water.
• It is passed through aseptic process.
