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Herbal formulations
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Table of Contents
1. Introduction:.......................................................................................................................3
2. Principal of Ayurveda ........................................................................................................3
3. Ayurvedic formulations .....................................................................................................4
3.1 Classification of dosage form ..........................................................................................4
3.1.1. Solid dosage form ....................................................................................................4
3.1.2. Semisolid dosage form.............................................................................................6
3.1.3. Liquid dosage form..................................................................................................8
3.2 Evaluation ......................................................................................................................10
3.2.1 Taxonomical estimation:.........................................................................................10
3.2.2 Organoleptic evaluation:.........................................................................................10
3.2.3 Foreign material Evaluation:...................................................................................11
3.2.4. Microscopic evaluation..........................................................................................11
3.2.5. Chromatographic Evaluation: ................................................................................11
3.2.6. Physiochemical Evaluation:...................................................................................12
3.2.7. Pharmacological parameter:...................................................................................13
3.2.8. Toxicological parameter: .......................................................................................14
3.2.9. Shelf-Life:..............................................................................................................14
3.3. Formulations .................................................................................................................14
3.3.1 Infusion ...................................................................................................................15
3.3.2. Decoction...............................................................................................................15
3.3.3. Tinctures.................................................................................................................16
3.3.4. Herbal capsules ......................................................................................................16
3.3.5. Herbal tablets .........................................................................................................17
3.3.6. Herbal ointments....................................................................................................17
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3.3.7. Herbal powders ......................................................................................................18
3.3.8. Herbal creams ........................................................................................................18
3.3.9. Herbal oils..............................................................................................................18
3.3.10 Herbal poultices and plasters ................................................................................19
3.3.11 Herbal compresses and fomentations....................................................................19
3.3.12 Herbal syrup..........................................................................................................19
3.3.13. Herbal Insect repellents........................................................................................19
3.3.15 Herbal washers......................................................................................................20
3.3.16 Herbal salves.........................................................................................................20
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Herbal Formulations
1. Introduction:
Ayurveda is one of the world's oldest holistic healing systems. It was developed more than
5,000 years ago and is often called the “Mother of All Healing.”. Ayurveda developed
significantly during the Vedic period and later some of the non-Vedic systems such as
Buddhism and Jainism also developed medical concepts and practices that appear in the
classical Ayurveda texts.[ It is based on the belief that health and wellness depend on a delicate
balance between the mind, body, and spirit. Its main goal is to promote good health, not fight
disease.
2. Principal of Ayurveda
According to Ayurvedic medicine, everything is composed of five elements. The five
elements are the building blocks of all matter. To create health and well-being, Ayurvedic
physicians and practitioners integrate various treatments that harmonize the following five
elements in both body and mind.
1. Air (Vayu)
2. Fire (Agni/Tejas)
3. Water (Jala)
4. Earth (Prithivi)
5. Space (Akasha)
Fig.1: Graphical representation of tridosha
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The five elements combine in sets of two to form unique bodily constitutions known as
doshas. (doshas) – vata, pitta, kapha representing the individual genetic code which takes
part in the forming of our mental and physical characteristics .during the course of life ,the
dosha proportions deviate (vikrti) from its original state (prakrti) for various reasons and
subsequently, it has an impact on our mental and physical health condition. Psychic
consciousness, thoughts, emotions, relationships, diet, daily rhythm, lifestyle, season and our
environment, all influence the balance or imbalance of the doshas. These three primary life
principles cannot be perceived separately and independently. Their functions are mutually
linked and complementary. To know the method or way of operating of each one of these
doshas enables us to correctly recognize their manifestations in combined constitutions,
which represent most frequent psychosomatic types.
Panchakarma is a Sanskrit word that means “five actions” or “five treatments”. This is a
process used to clean the body of toxic materials left by disease, poor nutrition and
environmental toxins. Panchakarma will remove the excess doshas and correct imbalances in
them as well as eliminate the harmful ama out of your system through the body’s own organs
and channels of elimination (colon, sweat glands, lungs, bladder, urinary tract, stomach,
intestines, etc). Panchakarma purifies the tissues at a very deep level.
3. Ayurvedic formulations
The importance of various dosage forms in ayurveda is to make it compatible and
palatable to the patient. In order to do this the potency of a drug can also be increased or
decreased. It is also used to increase the shelf life of the particular preparation. In accordance
with the roga, bala, prakruti and satmya of the patient dosage can be fixed.
3.1 Classification of dosage form
 Solid dosage forms
 Semi solid forms
 Liquid dosage forms
3.1.1. Solid dosage form
a. Gutika (Pills)
It is in the form of pills. They are made by using single or combinations of vegetable,
mineral or animal drugs. These preparations can be used up to 2 years. Pills with minerals can
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be used indefinitely. These formulations should not loose their original colour, odour, taste
and form on standing. They should be kept away from moisture, if they contain salt, ksara or
sugar.
Examples: Lasunadi gutika, Pranda gutika, Khadiradi gutika
b. Churna (Powders)
It is Fine powder of drug or drugs is known as churna. Drugs are cleaned properly, dried
thoroughly, pulverised and the sieved. The churna is free flowing and retains potency for one
year, if preserved in air-tight containers.
Examples: Triphala churna, Sudarshan churna, Trikatu churna, Drakshadi churna,
Sitopatadi churna
c. Satva
These are extract of herbs. A fresh herb is crushed into coarse mass and allowed to
remain in contact with water for about 12 hours. Then it is churned thoroughly and strained
through muslin. The strained liquid is allowed to stand for a few hours. The upper clear is
siphoned off and the sediment which contain active ingredient is dried into fine powder.
Examples: gulvel satva
d. Vati
It is solid preparation which is prepared either by cooking the powder of a drug with
jaggery, sugar or guggulu or without cooking. Then macerating the powder with liquid like
honey and guggulu and then rolled into pill forms. This form is considered to be the most
convenient form of medicine for the patient. It can also be used internally and externally and
can be used for many years.
Examples: Bilvadi gulika,Triphala guggulu
e. Lavana
It is one of the solid forms where the saindhavalavana is powdered and combined with
arka, narikela, and is covered and puta is given on agni so as to obtain a black coloured
lavana. It can be preserved for many years when kept in airtight containers,
Examples: Narikelalavana.
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f. Ksharas
Ksharas are alkaline substances which are obtained from the ash of drugs. It is used both
internally as well as externally. Internally used kshara is called paniyakshara and externally
used kshara is called pratisaraneeyakshara. It is again divided into three types i.e., mrudu,
madhyama and teekshnakshara. It is considered to be one of the anusastras and last
indefinitely.
Examples: Yavakshara, Apamargakshara.
g. Masika
Conversion of a drug into its carbon form by burning is called as masikalpana. The drug
from which masi is prepared should be powdered and placed in a sarava and samputa is
prepared by placing another sarava over the first one and sealing it. It is thus prepared by
giving either laghuputa or mahaputa according to the nature of the drugs involved. After the
cooling of the samputa, the prepared masi is ground once again to obtain a homogeneous and
fine powder
Example: Triphala masi.
h. Bhasma
The powdered form of the substances obtained by calcination of metals,
minerals or animal product by a special process in closed crucibles in pits covered with cow
dung cake (puta) is known as bhasma.
Example: Lauha Bhasma etc
i. Pistil
The pistil is a solid Ayurvedic preparation which is obtained by triturating the drug with
the specified liquids and then exposed to sunlight or moonlight
Example: Praval Pistil, and Mukta Pistil.
3.1.2. Semisolid dosage form
a. Kalka
Fresh herbs grounded into a fine or coarse paste is called Kalka. If the plant does not
yield appreciable quantities of juice, kalka is prepared. It has quite an amount of fibre and
therefore useful in digestive disorders because it stays longer in the gut. It is a soft paste
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prepared by both wet and dry drugs prepared by grinding wet and dry drugs. It is usually used
for external applications and if taken internally, the recommended dosage is 1 karsha (12 g).
Kalka is also used in the preparation of oils to add specific colour, fragrance and medicinal
properties. Examples: Nimba Kalka, Triphala kalka, and Rasonakalka.
b. Avaleha
It is another type of semi-solid preparation which is prepared either by adding jaggery
and/or sugar and is boiled with a prescribed drug, decoction of drug or its juice to get a semi-
solid preparation known as Avaleha. Avaleha contains an aqueous medium (kashaya,
swarasa, etc.), a substrate (sugar, sugar candy, jaggery), Oushada dravyas (powdered drugs),
lipid medium (Ghrita, Tila taila, etc.), and additives (honey, gingelly oil, salts). The
confirmatory tests for Avaleha preparation can be categorized into Asannapakalakshana and
Sidhalakshana which are mainly used to identify the Paka of Avaleha and it depends on
sweetening agent and water ratio. The dose is specified as one Karsha (12 g) to two Palas (96
g) based on the strength of the patient and severity of the disease.
Examples Kushmanda Avaleha, Soorana Avaleha, Chyavanaprasa, and Agastya
Rasayana .
c. Rasakriya
It is also another type of semi-solid preparation where the swarasa is extracted, boiled
down to thick consistency so as to obtain a semi-solid preparation known as Rasakriya. It is
used mainly for the bitter drugs, so it will be easier for consumption and the dosage of the
drug can be minimised. The process of the Rasakriya is considered to be similar to the
preparation of the aqueous extraction of the drug. The dosage of the drug can be reduced by
giving the drug in the Rasakriya form and also the palatability of the drug is still more
increased by adding sugar or jaggery to the Rasakriya and preparing it as syrup. This
increases the palatability and also helps for the easy absorption of the drug.
Generally, Rasakriya is prepared in two methods.
1. In the first method, juice or decoction is heated into a semisolid state and then fine
powders of the prakshepa dravyas are added.
2. In the second method, first jaggery or sugar is mixed with water and heated till it
becomes syrup and then the prescribed drugs are added,
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Example: Daruharidra Rasakriya.
d. Lepa
Lepas are external preparation used in the form of a paste. The method of preparation
involves powering the drugs and mixing with a liquid medium like water, ghee, cow’s urine
etc to make a soft paste.
Example: sinduradi lepa, and pathyadi lepa.
e. Matras
It is highly potent, sticky preparation which is applied to tongue where drug absorbed.
Drug is rubbed over sand stone in honey or milks like vehicle than collect it on fingertip and
applied to tongue.
f. Praash
It is highly palatable preparation used for refreshing or rejuvenations of the body.
3.1.3. Liquid dosage form
a. Swarasa
The juice extracted from the drug is known as swarasa.It is one of the basic preparations
in Ayurveda and one among the pancavidha kashaya kalpana and the most potent among
them.
Examples: Tulasi swarasa.
b. Kwatha
It is the another basic preparation where the coarse powder form of a drug is taken and it
is boiled with different ratio of water as in case of soft drugs 4 parts of water is used.
Example: rasnadi kwatha
c. Hima(cold infustion)
It is also one of the of the primary preparation mentioned in Ayurveda. One part of drug
is put in 6 part of cold water and kept overnight in an earthen pot. Next day the drug is taken
and macerated well and filtered through a clean cloth, and the formulation thus obtained is
called as the Hima kalpana. This type of preparation mainly acts as a pittashamaka and
hrudya and they can also be used as an instant source of energy.
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Examples: Dhanyaka hima. the dose of this kind of preparation is 2pala(96ml).the
upkalpana of hima are mantha kalpana, udaka kalpana ,panaka kalpana,
d. Arka
Arka kalpana can be defined as a secondary suspension preparation obtained by
distillation of certain liquids or of drugs soaked in water using the Arkayantra or any
convenient modern distillation apparatus. Arka is used in the case of agnimandya, amaajeerna
and amatisara.
Examples: Pudina Arka, Punarnava Arka, and Tulasi Arka.
e. Sarkara
The medicines in the syrup form are called sarkara. Here two parts of sugar is added to
one part of kwatha/swarasa/hima is added and heated on mandagni till it gets proper paka and
after cooling it is filtered and mainly used for children due to its sweetness and the sugar
concentration in this preparation will be 66.7% due to which it also acts as a preservative .
Examples: parushaka sarkara.
f. Asavarishta
Asava and Arishta are the special kinds of medicinal preparation which is made by
soaking the drugs either in the powder form or in the kashaya form in a solution of sugar or
jaggery for a specific period of time for fermentation to generate alcohol. The alcohol thus
generated acts as a preservative and thus facilitating the extraction of active principles
contained in it. It is preserved for many years.
Asava is preparation, which is prepared with the natural fermentation process using
herbs, water and sugar. Almost all Asava medicines do not include preparation of decoctions,
but it has very few exceptions.
Arishta is the type of ayurvedic medicines, which are prepared with natural fermentation
process using herbal decoctions, Dhataki flowers and sugar.
Examples: arjunarishta, draksarista, kanakasava, ashokarishta.
g. Phanta
It is also a preparation among the pancavidha kashaya kalpana as a hot infusion. Here the
coarse powder of a drug is put into hot water and it is rubbed and filtered with a cloth. By this
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there is softening of the drugs takes place as the extraction of all the volatile principles from
the drug to water.
h. Taila
Taila are preparations in which taila are boiled with a prescribed kashaya and kalka
according to the formula.
Examples: Triphalagrutha, Dhanwantara taila.
i. Ghrita
The preparation in which ghee is boiled with the prescribed quantity of the decoction
(kasaya) and fine paste (kalka) of the drug as specified in the formula. The process of
preparation of ghrita ensures the absorption of the therapeutically active constituents of the
drugs used in the preparation. Ghrita solifies when cooled.. Ghrita are preparation for internal
consumption and are stable for about 16 months. Normally they are taken along with warm
vehicle (water or milk). It can be preserved in glass, polythene or aluminium containers.
Examples: Asokaghrita, Nirgundi ghrita, Brahmi ghrita, Sukumara ghrita, Pippalyadi
ghrita.
3.2 Evaluation
3.2.1 Taxonomical estimation: - Authentication of drug material.
Herb authentication is a quality assurance process that ensures the correct plant species
and plant parts are used as raw materials for herbal medicines. The proper authentication of
herbal raw materials is critically important to the safety and efficacy of herbal medicines.
3.2.2 Organoleptic evaluation: - Colour, odour, taste, Particle morphology,
a. Colour: Colour represents external colour which various from white to brownish black are
essential diagnostic features.
b. Odour: The odour is examined by directly smelling of the powdered drug contained in a
package or freshly powdered.
c. Taste: The Taste of a drug is examined by taking a small quantity of powder by a tip of
moist glass rod and applying it on tongue previously rinsed with water. This may not be done
in case if poisonous drugs. Taste may be sweetish, sour, salt like and bitter or tasteless.
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d. Particle morphology: Shape of drug may be conical, sub cylindrical, cylindrical, fusiform
Size represents thickness, length, breadth and diameter.
3.2.3 Foreign material Evaluation: -Foreign plant, own plant, another animal, mineral.
Herbal drugs should be prepared from the confirmed part of the plant. They should be totally
free from insects or moulds, including visible and excreta contaminant such as stones, sand,
harmful and poisonous foreign matter and chemical residues. Animal objects such as insects
and invisible microbial contaminants, which produces toxins, as well as the potential
contaminants of herbal medicines. Macroscopic evaluation can easily use to determine the
presence of foreign matter.
3.2.4. Microscopic evaluation: -
Microscopic inspection of medicinal plant materials is indispensable for the identification of
broken or powdered materials; the specimen may have to be treated with chemical regents.
An examination by microscopy alone cannot always provide complete identification, though,
when used in association with other analytical methods, it can frequently supply invaluable
supporting evidence.
3.2.5. Chromatographic Evaluation: -HPLC, TLC, HPTLC, UV,GC.
a. HPLC: HPLC are widely used for isolating and purification of herbal compounds. There
are basically two types of preparative HPLC: low pressure HPLC (typically under 5 bar) and
high pressure HPLC (pressure >20 bar). The important parameters to be considered are
resolution, sensitivity and fast analysis time in analytical HPLC whereas both the degree of
solute purity as well as the amount of compound that can be produced per unit time. In
preparative HPLC (pressure >20 bar), larger stainless steel columns and packing materials
(particle size 10-30 μm are needed.
b. HPTLC: HPTLC technique is widely employed in pharmaceutical industry in process
development, identification and detection of adulterants in herbal product and helps in
identification of pesticide content, mycotoxins and in quality control of herbs and health
foods.
c. TLC: TLC is one of the most popular and simple chromatographic technique used of
separation of compounds. In the phytochemical evaluation of herbal drugs, TLC is being
employed extensively because It enables rapid analysis of herbal extracts with minimum
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sample clean-up requirement, It provides qualitative and semi quantitative information of the
resolved compounds. It enables the quantification of chemical constituent
d. GC: Gas Chromatography equipment can be directly interfaced with rapid scan mass
spectrometer of various types. GC and GC-MS are unanimously accepted methods for the
analysis of volatile constituents of herbal medicines, due to their sensitivity, stability and high
efficiency.
3.2.6. Physiochemical Evaluation: Following physiochemical parameters evaluated for
herbal drugs such as PH, Disintegration time, friability, hardness, sedimentation rate,
solubility, viscosity, ash value, extractive value, volatility, swelling index, foaming index,
melting range, and moisture content.
a. Foaming Index: Many medicinal plant materials contain saponins that can cause persistent
foam when an aqueous decoction is shaken. The foaming ability of an aqueous decoction of
plant materials and their extracts is measured in terms of a foaming index.
b. Swelling Index: The swelling index is the volume in ml taken up by the swelling of 1 gm
of plant material under specified conditions. Its determination is based on the addition of
water or a swelling agent as specified in the test procedure for each individual plant material.
Using a glass stoppered measuring cylinder, the material is shaken repeatedly for 1 hour and
then allowed to stand for a required period of time. The volume of the mixture is then read.
c. Extractive Values: Ethanol soluble extractive, 5 g of previously weighed air-dried drug
was taken in a stoppered flask to which 100 mL of 95% ethanol was added. It was shaken
continuously for 4 h on a magnetic stirrer. Then it was filtered rapidly taking precautions
against loss of the solvent.
d. pH measurement: pH meter was used for every sample of herbal durg the calibration with
buffer solution having acidic solution pH and basic solution pH .
e. Ash Value: Ash content is a measure of the amount of inorganic compound present in the
sample. To determine the ash content, measured amount of dry solid obtained from sample
was taken in a tarred silica dish and incinerated by gradually increasing the heat, not
exceeding dull red heat, until free from carbon. Then, the dish was allowed to cool in a
desiccator and weighed.
f. viscosity: Ostwald viscometer was used to determine the viscosity of herbal preparations.
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g .Volatility: The determination of volatile oils in the drug is performed by distillation with
water, collecting the distillate in a graduated tube with a structure such as allows that the
aqueous phase get separated from the oil phase and is returned to the distillation flask.
h. disintegration time : Disintegration test was performed using the digital microprocessor
based disintegration test apparatus by VEEGO. One capsule was introduced into each tube
and added a disc to each tube. The assembly was suspended in the water in a 1000 ml beaker.
The volume of water was such that the wire mesh at its highest point is at least 25 mm below
the surface of the water, and at its lower point was at least 25 mm above the bottom of the
beaker. The apparatus was operated and maintained the temperature at 370 ± 20C. Noted
down the time require to all capsules to disintegrate and pass through wire mesh.
i. Moisture content: The test was performed using Karl Fischer instrument by VEEGO.
3.2.7. Pharmacological parameter: -Bitterness, antimicrobial activity, haemolytic activity,
antioxidant activity.
a. Bitterness Value: The bitter properties of plant material are determined by comparing the
threshold bitter concentration of an extract of the materials with that of a dilute solution of
quinine hydrochloride. The bitterness value is expressed in units equivalent to the bitterness
of a solution containing 1 gm of quinine hydrochloride in 2000ml. Safe drinking water should
be used as a vehicle for the extraction of plant materials and for the mouth wash after each
tasting. Taste buds dull quickly if distilled water is used. The hardness of water rarely has any
significant influence on bitterness.
b. Haemolytic Activity: The haemolytic activity of plant materials, or a preparation
containing saponins, is determined by comparison with that of a reference material, saponin,
which has a haemolytic activity of 1000 units per gm. A suspension of erythrocytes is mixed
with equal volumes of a serial haemolysis and is determined after allowing the mixtures to
stand for a given period of time. A similar test is carried out simultaneously with saponin.
c. Antimicrobial activity: The antimicrobial assay showed that Chloroform, ethanol and
water exhibited in-vitro antibacterial activity against Gram-positive and Gram-negative
bacteria, whereas significant activity was not observed with petroleum ether extract.
d. Antioxidant activity: The assessment of antioxidant activity in phytotherapies is mostly
achieved by spectrophotometric assays; however colored substances can produce
interferences that do not occur in electro analytical methods.
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3.2.8. Toxicological parameter: - Limit test, pesticide contain, heavy metals, radioactive.
a. Radioactive Contamination: The microbial growth in herbal drugs is usually avoided by
irradiation. Dangerous contamination may be the consequence of a nuclear accident. The
WHO, has developed guidelines in the event of a wide spread contamination by radio
nuclides resulting from major nuclear accidents
b. Pesticide Content: Pesticides residue is any particular substance in food, agriculture
commodities or animal feed resulting from the use of a pesticides. Herbal drugs are prone to
contain pesticide residue, which gather from agricultural practices, such as Spraying,
behaviour of soil during cultivation and addition of fumigants during storage.
c. Limits for Heavy Metals: All Ayurvedic Drugs must comply with the limits for Heavy
Metals prescribed in individual Monograph and wherever limit is not given then they must
comply with the limits given in WHO publication “Quality Control Methods for Medicinal
Plants and Material”
3.2.9. Shelf-Life: It is recommended that in case of an herbal medicinal product containing a
natural product or a herbal drug preparation with constituents of known therapeutic activity,
the variation in component during the proposed. shelf-life should not exceed ± 5% of the
initial assay value, unless justified to widen the range up to ±10 per cent or even higher.
3.3. Herbal Formulations:
Herbal formulations means a dosage form consisting of one or more herbs or processed
herbs in specified quantities to provide specific nutritional, cosmetic benefits ,for use to
diagnose, treat, mitigate diseases of human beings or animals. Herbal formulations contain an
active substance or herbal substance or herbal preparation or herbal substance in combination
with one or more herbal preparations. Herbal formulations are obtained by subjecting herbal
substances to treatments such as extraction, distillation, expression, fractionation,
purification, concentration or fermentation include comminute or powdered. Whole,
fragmented or cut plants, plants parts, algae, fungi, lichen in an unprocessed, usually dried
form but sometimes fresh were used in the preparations of herbal formulations. Some herbal
formulations as follows.
Herbal formulations
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3.3.1 Infusion
Infusion is the process of extracting chemical compounds or flavours from plant material
in a solvent such as water, oil or alcohol, by allowing the material to remain suspended in the
solvent over time. Infusion is a chemical process that uses botanicals that are volatile and
release their active ingredients readily in water, oil, or alcohol.
In this process, a liquid is typically boiled (or brought to another appropriate
temperature) and poured over the herb. After the herb has been allowed to steep in the liquid
for an appropriate period of time, it is removed (possibly by straining) leaving an infusion.
Unless the infusion is to be consumed immediately, it is bottled and refrigerated for future
use.
There are several accessories and techniques for removing the steeped or leftover
botanicals that were used to infuse liquids, including metal steeper , tea infusers , and French
presses. The most commonly used technique is the teabag, which is made with filter paper
and filled with various tea flavours.
Many herbal teas are prepared by infusion, as well; lemon, chamomile, senna, apple,
ginger, rooibos, and many other plants are used individually or in combination. Herbal
infusions in water and oil are both commonly used as herbal remedies.
3.3.2. Decoction
Decoction is a method of extraction by boiling herbal or plant material to dissolve the
chemicals of the material, which may include stems, roots, bark and rhizomes.
It involves first mashing the plant material to allow for maximum dissolution, and then
boiling in water to extract oils, volatile organic compounds and other various chemical
substances. It can be used to make herbal tea, tinctures and similar solutions.
Decoctions and infusions may produce liquids with differing chemical properties as the
temperature and/or preparation difference may result in more oil-soluble chemicals in
decoctions versus infusions. The process can also be applied to meats and vegetables to
prepare bouillon or stock, though the term is typically only used to describe boiled plant
extracts, usually for medicinal or scientific purposes.
In herbalism, decoctions are usually made to extract fluids from hard plant materials such
as roots and bark. the plant material is usually boiled for 1–2 hours in 1-5 litres of water
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3.3.3. Tinctures
Tinctures are concentrated herbal extracts made by soaking the bark, berries, leaves
(dried or fresh), or roots from one or more plants in alcohol or vinegar. The alcohol or
vinegar pulls out the active ingredients in the plant parts, concentrating them as a liquid.
Many plant constituents dissolve more easily in a mixture of alcohol and water than in
pure water. The preparation of tinctures by maceration of herbal parts in water-ethanol
solutions results in the extraction of many structurally diverse compounds with varying
polarities.
An alcohol content of 25 %v/v is recommended for water-soluble constituents like
tannins, mucilage and certain flavonoids and some saponins, while an alcohol concentration
of 45-60 %v/v is required for alkaloids, essential oils, some glycosides and most saponins,
and 90 % v/v alcohol for resins and oleoresins. The use of the right ethanol concentration is
important in maximizing the quality of the herbal preparations.
Most tinctures have a shelf life of around five years. the tinctures used in phytotherapy
was found to be 6 mo and 3 mo, respectively, at 25 °C, due to the low thermal stability of the
constituents determined from accelerated and long term testing
. Improperly stored samples of Strong Iodine Tincture which had been subject to
household use for long periods showed iodine content much higher than that permitted by the
official pharmacopoeia.
3.3.4. Herbal capsules
Capsules are solid dosage forms containing drug and usually enclosed in a gelatin
container. Capsules may be available in hard gelatin for dry powdered herbal ingredients or
granules, or soft gelatin shells for herbal oils and for herbal ingredients that are dissolved or
suspended in oil. The gelatin shell readily ruptures and dissolves following oral
administration. Drugs are normally more readily released from capsules compared to tablets.
Capsules may help mask the unpleasant taste of its contents and uniformity of dosage can be
relatively readily achieved.
Herbal capsules normally consist of hard shelled gelatin capsules with the plant material
finely milled and sifted and filled into shell or extracts of the herbal material with appropriate
excipients such as fillers.
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The stability of herbal capsule preparations is relatively better when compared to
aqueous preparations such as decoctions and infusions. Stability and shelf life of capsule
preparations should be determined to provide appropriate instructions for storage of the
product. An accelerated stability study of herbal capsules indicated for immunomodulation
and stress in India found the change in quantifiable active components to be within 90% of
the initial amount showing the stability of the product at room temperature for 2 y.
Herbal capsules filled with pellets showed a uniform and stable release of phenolic
compounds in various long-term storage conditions, indicating that the method of preparation
of dry herbal extracts affects the stability of the active ingredients.
3.3.5. Herbal tablets
A tablet is a hard, compressed medication in round, oval or square shape The excipients
or formulation additives may include: binders, glidants and lubricants to ensure efficient
tableting; disintegrants to ensure that the tablet breaks up in the gastrointestinal tract;
sweeteners or flavours to mask the taste of bad tasting active ingredients; and pigments to
make uncoated tablets visually attractive.
A coating may be applied to a tablet to hide or mask the taste of the tablet's components,
make the tablet smoother and easier to swallow, protect drug from the acid secretions of the
stomach, and make it more resistant to environmental factors for stability purposes and
extend its shelf life.
Herbal tablets are normally designed for oral use with various herbal materials
incorporated for particular therapeutic effect using excipients. Incorporation of the herbal
material may be done with the finely powdered and sifted plant material or extracts from the
plant materials using various solvents which are suitable for oral use.
The stability of herbal tablets should be determined as the shelf life of the tablet is
affected by storage conditions.
3.3.6. Herbal ointments
Ointments are semi-solid, greasy preparations for application to the skin, rectum or nasal
mucosa. The base is usually anhydrous and immiscible with skin secretions. Ointments may
be used as emollients or to apply suspended or dissolved medicaments to the skin
Herbal formulations
18
. Herbal ointments normally have the plant material either in finely sifted or extracted
form incorporated into the base. It should not be used for deep wounds.
Ointments are relatively stable when compared with other liquid dosage forms. However,
the presence of herbal materials in an herbal ointment may lead to quick deterioration of the
product. The stability of herbal ointments is necessary to provide appropriate labelling
instructions for storage and shelf-life.
3.3.7. Herbal powders
These are preparations that come as powdered herbal materials meant for direct use or by
incorporation into foods, beverages for drinking insufflations, and wounds.
They may be finely sifted herbal materials from various parts of plants meant for a
particular therapeutic effect. Like the herbal teas, the stability of the powder depends on the
type and nature of the herbal material as well as the moisture content of the powder in the
bags and packaging. The dried herb and extract are stable under tropical room temperature
conditions for over one year in sealed glass containers.
3.3.8. Herbal creams
Creams are semi-solid emulsions that are mixtures of oil and water (hydrophilic). Herbal
creams normally contain the herbal material in either finely sifted form or incorporated as an
extract. Creams normally contain antimicrobial preservatives due to the presence of water in
the base and may have a relatively shorter shelf life compared to ointments.
3.3.9. Herbal oils
These are suspensions or solutions of herbal materials in an oily vehicle. Infused oils are
often called macerated oils, and should not be confused with essential oils, which are
aromatic oils isolated by distilling the plant material
. These preparations are normally meant for external or topical use as liniments. Some of
these preparations may be meant for oral use. Herbal materials such as leaves with essential
oils may normally be found incorporated in these oils
. The stability and shelf life of a herbal oil depends largely on the type of oil being used
in the extraction process since the stability of various essential oils differs.
Herbal formulations
19
3.3.10 Herbal poultices and plasters
Poultices are made by mashing fresh herbs, wrapping in gauze and applied to an affected
area of the skin after the temperature is suitable for application. Poultices may be used
externally to relax muscles or to ease minor skin eruptions, poison ivy, insect bites,
superficial wounds, and inflammation. Since they are normally made from fresh herbs, they
should be used immediately and cannot be stored.
3.3.11 Herbal compresses and fomentations
Compresses are normally prepared from an infusion or tincture in hot or cold water by
soaking a cotton cloth or gauze. Compresses may be used externally and can be either warm
or cold. Cold compresses reduce inflammation and help to relieve pain.
They are usually used in the treatment of sprains, contusions, strains, inflammation,
headaches, and insect bites. Warm compresses are used to increase circulation to an area and
to allow muscles, tendons, and ligaments to stretch.
3.3.12 Herbal syrup
Herbal syrup is prepared by combining a concentrated decoction with either honey or
sugar, and sometimes alcohol. The base of such syrup is a strong herbal decoction. Mixing a
decoction with honey or sugar helps to thicken and preserve the decoction. This increases the
shelf life of the decoction and often creates a soothing application that benefits situations
such as sore throat, cough, dry irritated tissues, and digestive issues. The added sweetener can
also help to increase the palatability of some herbs.
The basic proportions you want to use are 2 parts herbal decoction to 1 part honey or
sugar. This is called a 2:1 ratio. This means that if you start with your herbs added to 4 cups
of water and simmer down the liquid to 2 cups of decoction, then you will want to add 1 cup
of honey or sugar to create and adequately preserve your syrup.
3.3.13. Herbal Insect repellents
It help prevent and control the outbreak of insect-borne diseases such as malaria, dengue
fever, bubonic plague, river blindness and West Nile fever.
Pest animals commonly serving as vectors for disease include insects such as flea, fly,
and mosquito; and the arachnid tick Some insect repellents are insecticides but most simply
discourage insects and send them flying or crawling away. Almost any might kill at a massive
Herbal formulations
20
dose without reprieve, but classification as an insecticide implies death even at lower
doses.Essential oil repellents can be short-lived in their effectiveness, since essential oils can
evaporate completely.
3.3.14 Herbal lotion
Herbal lotion is a low-viscosity topical preparation intended for application to the skin.
By contrast, creams and gels have higher viscosity, typically due to lower water content.
Lotions are applied to external skin with bare hands, a brush, a clean cloth, or cotton wool.
3.3.15 Herbal washers
Herbal Shampoo is preparation of surfactant in suitable form liquid, solid or powder,
which when used under the condition specified will remove surface grease, dirt and skin
debris from the hair shaft and scalp without affecting adversely the hair, scalp or health of the
user. E.g: Accacia concinna .
Herbal soap is a salt of a fatty acid usually made by saponification of a fatty acid with
caustic soda or a suitable base. Herbal soaps have the herbal materials incorporated in the
detergent base. These herbal materials normally have an antifungal and antibacterial effect on
the skin and helps in cleansing of the skin. Herbal soaps are normally meant for microbial
skin conditions such as dandruff, eczema, ringworm and boils. Soaps have a relatively longer
shelf-life when preservatives or antioxidants are added.
3.3.16 Herbal salves
These are such a simple, effective, and useful way to take in herbal goodness. They can
easily be slipped into a purse, pocket, or first aid kit. Although semi-solid at room
temperature, salves soften once applied to the skin, making them less messy than oils.
They also make great gifts and are an easy and approachable way to introduce newbies to
the power of herbs. Plus, salves can be crafted for a wide variety of topical uses. The addition
of beeswax will protect, soothe, and nourish your skin.
Conclusion:
Herbal products may contain a single herb or combinations of several different herbs believed
to have complementary and/ or synergistic effects. Some herbal products, including many
Herbal formulations
21
traditional medicine formulations, also include animal products and minerals. Herbal
products are sold as either raw plants or extracts of portions of the plant. In addition to this,
these studies also provide information of of the drug. Thus, this holds great promise for future
research for the formulation of potent antidiabetic drug for the present plant.

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Herbal formulation chapter

  • 1. Herbal formulations 1 Table of Contents 1. Introduction:.......................................................................................................................3 2. Principal of Ayurveda ........................................................................................................3 3. Ayurvedic formulations .....................................................................................................4 3.1 Classification of dosage form ..........................................................................................4 3.1.1. Solid dosage form ....................................................................................................4 3.1.2. Semisolid dosage form.............................................................................................6 3.1.3. Liquid dosage form..................................................................................................8 3.2 Evaluation ......................................................................................................................10 3.2.1 Taxonomical estimation:.........................................................................................10 3.2.2 Organoleptic evaluation:.........................................................................................10 3.2.3 Foreign material Evaluation:...................................................................................11 3.2.4. Microscopic evaluation..........................................................................................11 3.2.5. Chromatographic Evaluation: ................................................................................11 3.2.6. Physiochemical Evaluation:...................................................................................12 3.2.7. Pharmacological parameter:...................................................................................13 3.2.8. Toxicological parameter: .......................................................................................14 3.2.9. Shelf-Life:..............................................................................................................14 3.3. Formulations .................................................................................................................14 3.3.1 Infusion ...................................................................................................................15 3.3.2. Decoction...............................................................................................................15 3.3.3. Tinctures.................................................................................................................16 3.3.4. Herbal capsules ......................................................................................................16 3.3.5. Herbal tablets .........................................................................................................17 3.3.6. Herbal ointments....................................................................................................17
  • 2. Herbal formulations 2 3.3.7. Herbal powders ......................................................................................................18 3.3.8. Herbal creams ........................................................................................................18 3.3.9. Herbal oils..............................................................................................................18 3.3.10 Herbal poultices and plasters ................................................................................19 3.3.11 Herbal compresses and fomentations....................................................................19 3.3.12 Herbal syrup..........................................................................................................19 3.3.13. Herbal Insect repellents........................................................................................19 3.3.15 Herbal washers......................................................................................................20 3.3.16 Herbal salves.........................................................................................................20
  • 3. Herbal formulations 3 Herbal Formulations 1. Introduction: Ayurveda is one of the world's oldest holistic healing systems. It was developed more than 5,000 years ago and is often called the “Mother of All Healing.”. Ayurveda developed significantly during the Vedic period and later some of the non-Vedic systems such as Buddhism and Jainism also developed medical concepts and practices that appear in the classical Ayurveda texts.[ It is based on the belief that health and wellness depend on a delicate balance between the mind, body, and spirit. Its main goal is to promote good health, not fight disease. 2. Principal of Ayurveda According to Ayurvedic medicine, everything is composed of five elements. The five elements are the building blocks of all matter. To create health and well-being, Ayurvedic physicians and practitioners integrate various treatments that harmonize the following five elements in both body and mind. 1. Air (Vayu) 2. Fire (Agni/Tejas) 3. Water (Jala) 4. Earth (Prithivi) 5. Space (Akasha) Fig.1: Graphical representation of tridosha
  • 4. Herbal formulations 4 The five elements combine in sets of two to form unique bodily constitutions known as doshas. (doshas) – vata, pitta, kapha representing the individual genetic code which takes part in the forming of our mental and physical characteristics .during the course of life ,the dosha proportions deviate (vikrti) from its original state (prakrti) for various reasons and subsequently, it has an impact on our mental and physical health condition. Psychic consciousness, thoughts, emotions, relationships, diet, daily rhythm, lifestyle, season and our environment, all influence the balance or imbalance of the doshas. These three primary life principles cannot be perceived separately and independently. Their functions are mutually linked and complementary. To know the method or way of operating of each one of these doshas enables us to correctly recognize their manifestations in combined constitutions, which represent most frequent psychosomatic types. Panchakarma is a Sanskrit word that means “five actions” or “five treatments”. This is a process used to clean the body of toxic materials left by disease, poor nutrition and environmental toxins. Panchakarma will remove the excess doshas and correct imbalances in them as well as eliminate the harmful ama out of your system through the body’s own organs and channels of elimination (colon, sweat glands, lungs, bladder, urinary tract, stomach, intestines, etc). Panchakarma purifies the tissues at a very deep level. 3. Ayurvedic formulations The importance of various dosage forms in ayurveda is to make it compatible and palatable to the patient. In order to do this the potency of a drug can also be increased or decreased. It is also used to increase the shelf life of the particular preparation. In accordance with the roga, bala, prakruti and satmya of the patient dosage can be fixed. 3.1 Classification of dosage form  Solid dosage forms  Semi solid forms  Liquid dosage forms 3.1.1. Solid dosage form a. Gutika (Pills) It is in the form of pills. They are made by using single or combinations of vegetable, mineral or animal drugs. These preparations can be used up to 2 years. Pills with minerals can
  • 5. Herbal formulations 5 be used indefinitely. These formulations should not loose their original colour, odour, taste and form on standing. They should be kept away from moisture, if they contain salt, ksara or sugar. Examples: Lasunadi gutika, Pranda gutika, Khadiradi gutika b. Churna (Powders) It is Fine powder of drug or drugs is known as churna. Drugs are cleaned properly, dried thoroughly, pulverised and the sieved. The churna is free flowing and retains potency for one year, if preserved in air-tight containers. Examples: Triphala churna, Sudarshan churna, Trikatu churna, Drakshadi churna, Sitopatadi churna c. Satva These are extract of herbs. A fresh herb is crushed into coarse mass and allowed to remain in contact with water for about 12 hours. Then it is churned thoroughly and strained through muslin. The strained liquid is allowed to stand for a few hours. The upper clear is siphoned off and the sediment which contain active ingredient is dried into fine powder. Examples: gulvel satva d. Vati It is solid preparation which is prepared either by cooking the powder of a drug with jaggery, sugar or guggulu or without cooking. Then macerating the powder with liquid like honey and guggulu and then rolled into pill forms. This form is considered to be the most convenient form of medicine for the patient. It can also be used internally and externally and can be used for many years. Examples: Bilvadi gulika,Triphala guggulu e. Lavana It is one of the solid forms where the saindhavalavana is powdered and combined with arka, narikela, and is covered and puta is given on agni so as to obtain a black coloured lavana. It can be preserved for many years when kept in airtight containers, Examples: Narikelalavana.
  • 6. Herbal formulations 6 f. Ksharas Ksharas are alkaline substances which are obtained from the ash of drugs. It is used both internally as well as externally. Internally used kshara is called paniyakshara and externally used kshara is called pratisaraneeyakshara. It is again divided into three types i.e., mrudu, madhyama and teekshnakshara. It is considered to be one of the anusastras and last indefinitely. Examples: Yavakshara, Apamargakshara. g. Masika Conversion of a drug into its carbon form by burning is called as masikalpana. The drug from which masi is prepared should be powdered and placed in a sarava and samputa is prepared by placing another sarava over the first one and sealing it. It is thus prepared by giving either laghuputa or mahaputa according to the nature of the drugs involved. After the cooling of the samputa, the prepared masi is ground once again to obtain a homogeneous and fine powder Example: Triphala masi. h. Bhasma The powdered form of the substances obtained by calcination of metals, minerals or animal product by a special process in closed crucibles in pits covered with cow dung cake (puta) is known as bhasma. Example: Lauha Bhasma etc i. Pistil The pistil is a solid Ayurvedic preparation which is obtained by triturating the drug with the specified liquids and then exposed to sunlight or moonlight Example: Praval Pistil, and Mukta Pistil. 3.1.2. Semisolid dosage form a. Kalka Fresh herbs grounded into a fine or coarse paste is called Kalka. If the plant does not yield appreciable quantities of juice, kalka is prepared. It has quite an amount of fibre and therefore useful in digestive disorders because it stays longer in the gut. It is a soft paste
  • 7. Herbal formulations 7 prepared by both wet and dry drugs prepared by grinding wet and dry drugs. It is usually used for external applications and if taken internally, the recommended dosage is 1 karsha (12 g). Kalka is also used in the preparation of oils to add specific colour, fragrance and medicinal properties. Examples: Nimba Kalka, Triphala kalka, and Rasonakalka. b. Avaleha It is another type of semi-solid preparation which is prepared either by adding jaggery and/or sugar and is boiled with a prescribed drug, decoction of drug or its juice to get a semi- solid preparation known as Avaleha. Avaleha contains an aqueous medium (kashaya, swarasa, etc.), a substrate (sugar, sugar candy, jaggery), Oushada dravyas (powdered drugs), lipid medium (Ghrita, Tila taila, etc.), and additives (honey, gingelly oil, salts). The confirmatory tests for Avaleha preparation can be categorized into Asannapakalakshana and Sidhalakshana which are mainly used to identify the Paka of Avaleha and it depends on sweetening agent and water ratio. The dose is specified as one Karsha (12 g) to two Palas (96 g) based on the strength of the patient and severity of the disease. Examples Kushmanda Avaleha, Soorana Avaleha, Chyavanaprasa, and Agastya Rasayana . c. Rasakriya It is also another type of semi-solid preparation where the swarasa is extracted, boiled down to thick consistency so as to obtain a semi-solid preparation known as Rasakriya. It is used mainly for the bitter drugs, so it will be easier for consumption and the dosage of the drug can be minimised. The process of the Rasakriya is considered to be similar to the preparation of the aqueous extraction of the drug. The dosage of the drug can be reduced by giving the drug in the Rasakriya form and also the palatability of the drug is still more increased by adding sugar or jaggery to the Rasakriya and preparing it as syrup. This increases the palatability and also helps for the easy absorption of the drug. Generally, Rasakriya is prepared in two methods. 1. In the first method, juice or decoction is heated into a semisolid state and then fine powders of the prakshepa dravyas are added. 2. In the second method, first jaggery or sugar is mixed with water and heated till it becomes syrup and then the prescribed drugs are added,
  • 8. Herbal formulations 8 Example: Daruharidra Rasakriya. d. Lepa Lepas are external preparation used in the form of a paste. The method of preparation involves powering the drugs and mixing with a liquid medium like water, ghee, cow’s urine etc to make a soft paste. Example: sinduradi lepa, and pathyadi lepa. e. Matras It is highly potent, sticky preparation which is applied to tongue where drug absorbed. Drug is rubbed over sand stone in honey or milks like vehicle than collect it on fingertip and applied to tongue. f. Praash It is highly palatable preparation used for refreshing or rejuvenations of the body. 3.1.3. Liquid dosage form a. Swarasa The juice extracted from the drug is known as swarasa.It is one of the basic preparations in Ayurveda and one among the pancavidha kashaya kalpana and the most potent among them. Examples: Tulasi swarasa. b. Kwatha It is the another basic preparation where the coarse powder form of a drug is taken and it is boiled with different ratio of water as in case of soft drugs 4 parts of water is used. Example: rasnadi kwatha c. Hima(cold infustion) It is also one of the of the primary preparation mentioned in Ayurveda. One part of drug is put in 6 part of cold water and kept overnight in an earthen pot. Next day the drug is taken and macerated well and filtered through a clean cloth, and the formulation thus obtained is called as the Hima kalpana. This type of preparation mainly acts as a pittashamaka and hrudya and they can also be used as an instant source of energy.
  • 9. Herbal formulations 9 Examples: Dhanyaka hima. the dose of this kind of preparation is 2pala(96ml).the upkalpana of hima are mantha kalpana, udaka kalpana ,panaka kalpana, d. Arka Arka kalpana can be defined as a secondary suspension preparation obtained by distillation of certain liquids or of drugs soaked in water using the Arkayantra or any convenient modern distillation apparatus. Arka is used in the case of agnimandya, amaajeerna and amatisara. Examples: Pudina Arka, Punarnava Arka, and Tulasi Arka. e. Sarkara The medicines in the syrup form are called sarkara. Here two parts of sugar is added to one part of kwatha/swarasa/hima is added and heated on mandagni till it gets proper paka and after cooling it is filtered and mainly used for children due to its sweetness and the sugar concentration in this preparation will be 66.7% due to which it also acts as a preservative . Examples: parushaka sarkara. f. Asavarishta Asava and Arishta are the special kinds of medicinal preparation which is made by soaking the drugs either in the powder form or in the kashaya form in a solution of sugar or jaggery for a specific period of time for fermentation to generate alcohol. The alcohol thus generated acts as a preservative and thus facilitating the extraction of active principles contained in it. It is preserved for many years. Asava is preparation, which is prepared with the natural fermentation process using herbs, water and sugar. Almost all Asava medicines do not include preparation of decoctions, but it has very few exceptions. Arishta is the type of ayurvedic medicines, which are prepared with natural fermentation process using herbal decoctions, Dhataki flowers and sugar. Examples: arjunarishta, draksarista, kanakasava, ashokarishta. g. Phanta It is also a preparation among the pancavidha kashaya kalpana as a hot infusion. Here the coarse powder of a drug is put into hot water and it is rubbed and filtered with a cloth. By this
  • 10. Herbal formulations 10 there is softening of the drugs takes place as the extraction of all the volatile principles from the drug to water. h. Taila Taila are preparations in which taila are boiled with a prescribed kashaya and kalka according to the formula. Examples: Triphalagrutha, Dhanwantara taila. i. Ghrita The preparation in which ghee is boiled with the prescribed quantity of the decoction (kasaya) and fine paste (kalka) of the drug as specified in the formula. The process of preparation of ghrita ensures the absorption of the therapeutically active constituents of the drugs used in the preparation. Ghrita solifies when cooled.. Ghrita are preparation for internal consumption and are stable for about 16 months. Normally they are taken along with warm vehicle (water or milk). It can be preserved in glass, polythene or aluminium containers. Examples: Asokaghrita, Nirgundi ghrita, Brahmi ghrita, Sukumara ghrita, Pippalyadi ghrita. 3.2 Evaluation 3.2.1 Taxonomical estimation: - Authentication of drug material. Herb authentication is a quality assurance process that ensures the correct plant species and plant parts are used as raw materials for herbal medicines. The proper authentication of herbal raw materials is critically important to the safety and efficacy of herbal medicines. 3.2.2 Organoleptic evaluation: - Colour, odour, taste, Particle morphology, a. Colour: Colour represents external colour which various from white to brownish black are essential diagnostic features. b. Odour: The odour is examined by directly smelling of the powdered drug contained in a package or freshly powdered. c. Taste: The Taste of a drug is examined by taking a small quantity of powder by a tip of moist glass rod and applying it on tongue previously rinsed with water. This may not be done in case if poisonous drugs. Taste may be sweetish, sour, salt like and bitter or tasteless.
  • 11. Herbal formulations 11 d. Particle morphology: Shape of drug may be conical, sub cylindrical, cylindrical, fusiform Size represents thickness, length, breadth and diameter. 3.2.3 Foreign material Evaluation: -Foreign plant, own plant, another animal, mineral. Herbal drugs should be prepared from the confirmed part of the plant. They should be totally free from insects or moulds, including visible and excreta contaminant such as stones, sand, harmful and poisonous foreign matter and chemical residues. Animal objects such as insects and invisible microbial contaminants, which produces toxins, as well as the potential contaminants of herbal medicines. Macroscopic evaluation can easily use to determine the presence of foreign matter. 3.2.4. Microscopic evaluation: - Microscopic inspection of medicinal plant materials is indispensable for the identification of broken or powdered materials; the specimen may have to be treated with chemical regents. An examination by microscopy alone cannot always provide complete identification, though, when used in association with other analytical methods, it can frequently supply invaluable supporting evidence. 3.2.5. Chromatographic Evaluation: -HPLC, TLC, HPTLC, UV,GC. a. HPLC: HPLC are widely used for isolating and purification of herbal compounds. There are basically two types of preparative HPLC: low pressure HPLC (typically under 5 bar) and high pressure HPLC (pressure >20 bar). The important parameters to be considered are resolution, sensitivity and fast analysis time in analytical HPLC whereas both the degree of solute purity as well as the amount of compound that can be produced per unit time. In preparative HPLC (pressure >20 bar), larger stainless steel columns and packing materials (particle size 10-30 μm are needed. b. HPTLC: HPTLC technique is widely employed in pharmaceutical industry in process development, identification and detection of adulterants in herbal product and helps in identification of pesticide content, mycotoxins and in quality control of herbs and health foods. c. TLC: TLC is one of the most popular and simple chromatographic technique used of separation of compounds. In the phytochemical evaluation of herbal drugs, TLC is being employed extensively because It enables rapid analysis of herbal extracts with minimum
  • 12. Herbal formulations 12 sample clean-up requirement, It provides qualitative and semi quantitative information of the resolved compounds. It enables the quantification of chemical constituent d. GC: Gas Chromatography equipment can be directly interfaced with rapid scan mass spectrometer of various types. GC and GC-MS are unanimously accepted methods for the analysis of volatile constituents of herbal medicines, due to their sensitivity, stability and high efficiency. 3.2.6. Physiochemical Evaluation: Following physiochemical parameters evaluated for herbal drugs such as PH, Disintegration time, friability, hardness, sedimentation rate, solubility, viscosity, ash value, extractive value, volatility, swelling index, foaming index, melting range, and moisture content. a. Foaming Index: Many medicinal plant materials contain saponins that can cause persistent foam when an aqueous decoction is shaken. The foaming ability of an aqueous decoction of plant materials and their extracts is measured in terms of a foaming index. b. Swelling Index: The swelling index is the volume in ml taken up by the swelling of 1 gm of plant material under specified conditions. Its determination is based on the addition of water or a swelling agent as specified in the test procedure for each individual plant material. Using a glass stoppered measuring cylinder, the material is shaken repeatedly for 1 hour and then allowed to stand for a required period of time. The volume of the mixture is then read. c. Extractive Values: Ethanol soluble extractive, 5 g of previously weighed air-dried drug was taken in a stoppered flask to which 100 mL of 95% ethanol was added. It was shaken continuously for 4 h on a magnetic stirrer. Then it was filtered rapidly taking precautions against loss of the solvent. d. pH measurement: pH meter was used for every sample of herbal durg the calibration with buffer solution having acidic solution pH and basic solution pH . e. Ash Value: Ash content is a measure of the amount of inorganic compound present in the sample. To determine the ash content, measured amount of dry solid obtained from sample was taken in a tarred silica dish and incinerated by gradually increasing the heat, not exceeding dull red heat, until free from carbon. Then, the dish was allowed to cool in a desiccator and weighed. f. viscosity: Ostwald viscometer was used to determine the viscosity of herbal preparations.
  • 13. Herbal formulations 13 g .Volatility: The determination of volatile oils in the drug is performed by distillation with water, collecting the distillate in a graduated tube with a structure such as allows that the aqueous phase get separated from the oil phase and is returned to the distillation flask. h. disintegration time : Disintegration test was performed using the digital microprocessor based disintegration test apparatus by VEEGO. One capsule was introduced into each tube and added a disc to each tube. The assembly was suspended in the water in a 1000 ml beaker. The volume of water was such that the wire mesh at its highest point is at least 25 mm below the surface of the water, and at its lower point was at least 25 mm above the bottom of the beaker. The apparatus was operated and maintained the temperature at 370 ± 20C. Noted down the time require to all capsules to disintegrate and pass through wire mesh. i. Moisture content: The test was performed using Karl Fischer instrument by VEEGO. 3.2.7. Pharmacological parameter: -Bitterness, antimicrobial activity, haemolytic activity, antioxidant activity. a. Bitterness Value: The bitter properties of plant material are determined by comparing the threshold bitter concentration of an extract of the materials with that of a dilute solution of quinine hydrochloride. The bitterness value is expressed in units equivalent to the bitterness of a solution containing 1 gm of quinine hydrochloride in 2000ml. Safe drinking water should be used as a vehicle for the extraction of plant materials and for the mouth wash after each tasting. Taste buds dull quickly if distilled water is used. The hardness of water rarely has any significant influence on bitterness. b. Haemolytic Activity: The haemolytic activity of plant materials, or a preparation containing saponins, is determined by comparison with that of a reference material, saponin, which has a haemolytic activity of 1000 units per gm. A suspension of erythrocytes is mixed with equal volumes of a serial haemolysis and is determined after allowing the mixtures to stand for a given period of time. A similar test is carried out simultaneously with saponin. c. Antimicrobial activity: The antimicrobial assay showed that Chloroform, ethanol and water exhibited in-vitro antibacterial activity against Gram-positive and Gram-negative bacteria, whereas significant activity was not observed with petroleum ether extract. d. Antioxidant activity: The assessment of antioxidant activity in phytotherapies is mostly achieved by spectrophotometric assays; however colored substances can produce interferences that do not occur in electro analytical methods.
  • 14. Herbal formulations 14 3.2.8. Toxicological parameter: - Limit test, pesticide contain, heavy metals, radioactive. a. Radioactive Contamination: The microbial growth in herbal drugs is usually avoided by irradiation. Dangerous contamination may be the consequence of a nuclear accident. The WHO, has developed guidelines in the event of a wide spread contamination by radio nuclides resulting from major nuclear accidents b. Pesticide Content: Pesticides residue is any particular substance in food, agriculture commodities or animal feed resulting from the use of a pesticides. Herbal drugs are prone to contain pesticide residue, which gather from agricultural practices, such as Spraying, behaviour of soil during cultivation and addition of fumigants during storage. c. Limits for Heavy Metals: All Ayurvedic Drugs must comply with the limits for Heavy Metals prescribed in individual Monograph and wherever limit is not given then they must comply with the limits given in WHO publication “Quality Control Methods for Medicinal Plants and Material” 3.2.9. Shelf-Life: It is recommended that in case of an herbal medicinal product containing a natural product or a herbal drug preparation with constituents of known therapeutic activity, the variation in component during the proposed. shelf-life should not exceed ± 5% of the initial assay value, unless justified to widen the range up to ±10 per cent or even higher. 3.3. Herbal Formulations: Herbal formulations means a dosage form consisting of one or more herbs or processed herbs in specified quantities to provide specific nutritional, cosmetic benefits ,for use to diagnose, treat, mitigate diseases of human beings or animals. Herbal formulations contain an active substance or herbal substance or herbal preparation or herbal substance in combination with one or more herbal preparations. Herbal formulations are obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation include comminute or powdered. Whole, fragmented or cut plants, plants parts, algae, fungi, lichen in an unprocessed, usually dried form but sometimes fresh were used in the preparations of herbal formulations. Some herbal formulations as follows.
  • 15. Herbal formulations 15 3.3.1 Infusion Infusion is the process of extracting chemical compounds or flavours from plant material in a solvent such as water, oil or alcohol, by allowing the material to remain suspended in the solvent over time. Infusion is a chemical process that uses botanicals that are volatile and release their active ingredients readily in water, oil, or alcohol. In this process, a liquid is typically boiled (or brought to another appropriate temperature) and poured over the herb. After the herb has been allowed to steep in the liquid for an appropriate period of time, it is removed (possibly by straining) leaving an infusion. Unless the infusion is to be consumed immediately, it is bottled and refrigerated for future use. There are several accessories and techniques for removing the steeped or leftover botanicals that were used to infuse liquids, including metal steeper , tea infusers , and French presses. The most commonly used technique is the teabag, which is made with filter paper and filled with various tea flavours. Many herbal teas are prepared by infusion, as well; lemon, chamomile, senna, apple, ginger, rooibos, and many other plants are used individually or in combination. Herbal infusions in water and oil are both commonly used as herbal remedies. 3.3.2. Decoction Decoction is a method of extraction by boiling herbal or plant material to dissolve the chemicals of the material, which may include stems, roots, bark and rhizomes. It involves first mashing the plant material to allow for maximum dissolution, and then boiling in water to extract oils, volatile organic compounds and other various chemical substances. It can be used to make herbal tea, tinctures and similar solutions. Decoctions and infusions may produce liquids with differing chemical properties as the temperature and/or preparation difference may result in more oil-soluble chemicals in decoctions versus infusions. The process can also be applied to meats and vegetables to prepare bouillon or stock, though the term is typically only used to describe boiled plant extracts, usually for medicinal or scientific purposes. In herbalism, decoctions are usually made to extract fluids from hard plant materials such as roots and bark. the plant material is usually boiled for 1–2 hours in 1-5 litres of water
  • 16. Herbal formulations 16 3.3.3. Tinctures Tinctures are concentrated herbal extracts made by soaking the bark, berries, leaves (dried or fresh), or roots from one or more plants in alcohol or vinegar. The alcohol or vinegar pulls out the active ingredients in the plant parts, concentrating them as a liquid. Many plant constituents dissolve more easily in a mixture of alcohol and water than in pure water. The preparation of tinctures by maceration of herbal parts in water-ethanol solutions results in the extraction of many structurally diverse compounds with varying polarities. An alcohol content of 25 %v/v is recommended for water-soluble constituents like tannins, mucilage and certain flavonoids and some saponins, while an alcohol concentration of 45-60 %v/v is required for alkaloids, essential oils, some glycosides and most saponins, and 90 % v/v alcohol for resins and oleoresins. The use of the right ethanol concentration is important in maximizing the quality of the herbal preparations. Most tinctures have a shelf life of around five years. the tinctures used in phytotherapy was found to be 6 mo and 3 mo, respectively, at 25 °C, due to the low thermal stability of the constituents determined from accelerated and long term testing . Improperly stored samples of Strong Iodine Tincture which had been subject to household use for long periods showed iodine content much higher than that permitted by the official pharmacopoeia. 3.3.4. Herbal capsules Capsules are solid dosage forms containing drug and usually enclosed in a gelatin container. Capsules may be available in hard gelatin for dry powdered herbal ingredients or granules, or soft gelatin shells for herbal oils and for herbal ingredients that are dissolved or suspended in oil. The gelatin shell readily ruptures and dissolves following oral administration. Drugs are normally more readily released from capsules compared to tablets. Capsules may help mask the unpleasant taste of its contents and uniformity of dosage can be relatively readily achieved. Herbal capsules normally consist of hard shelled gelatin capsules with the plant material finely milled and sifted and filled into shell or extracts of the herbal material with appropriate excipients such as fillers.
  • 17. Herbal formulations 17 The stability of herbal capsule preparations is relatively better when compared to aqueous preparations such as decoctions and infusions. Stability and shelf life of capsule preparations should be determined to provide appropriate instructions for storage of the product. An accelerated stability study of herbal capsules indicated for immunomodulation and stress in India found the change in quantifiable active components to be within 90% of the initial amount showing the stability of the product at room temperature for 2 y. Herbal capsules filled with pellets showed a uniform and stable release of phenolic compounds in various long-term storage conditions, indicating that the method of preparation of dry herbal extracts affects the stability of the active ingredients. 3.3.5. Herbal tablets A tablet is a hard, compressed medication in round, oval or square shape The excipients or formulation additives may include: binders, glidants and lubricants to ensure efficient tableting; disintegrants to ensure that the tablet breaks up in the gastrointestinal tract; sweeteners or flavours to mask the taste of bad tasting active ingredients; and pigments to make uncoated tablets visually attractive. A coating may be applied to a tablet to hide or mask the taste of the tablet's components, make the tablet smoother and easier to swallow, protect drug from the acid secretions of the stomach, and make it more resistant to environmental factors for stability purposes and extend its shelf life. Herbal tablets are normally designed for oral use with various herbal materials incorporated for particular therapeutic effect using excipients. Incorporation of the herbal material may be done with the finely powdered and sifted plant material or extracts from the plant materials using various solvents which are suitable for oral use. The stability of herbal tablets should be determined as the shelf life of the tablet is affected by storage conditions. 3.3.6. Herbal ointments Ointments are semi-solid, greasy preparations for application to the skin, rectum or nasal mucosa. The base is usually anhydrous and immiscible with skin secretions. Ointments may be used as emollients or to apply suspended or dissolved medicaments to the skin
  • 18. Herbal formulations 18 . Herbal ointments normally have the plant material either in finely sifted or extracted form incorporated into the base. It should not be used for deep wounds. Ointments are relatively stable when compared with other liquid dosage forms. However, the presence of herbal materials in an herbal ointment may lead to quick deterioration of the product. The stability of herbal ointments is necessary to provide appropriate labelling instructions for storage and shelf-life. 3.3.7. Herbal powders These are preparations that come as powdered herbal materials meant for direct use or by incorporation into foods, beverages for drinking insufflations, and wounds. They may be finely sifted herbal materials from various parts of plants meant for a particular therapeutic effect. Like the herbal teas, the stability of the powder depends on the type and nature of the herbal material as well as the moisture content of the powder in the bags and packaging. The dried herb and extract are stable under tropical room temperature conditions for over one year in sealed glass containers. 3.3.8. Herbal creams Creams are semi-solid emulsions that are mixtures of oil and water (hydrophilic). Herbal creams normally contain the herbal material in either finely sifted form or incorporated as an extract. Creams normally contain antimicrobial preservatives due to the presence of water in the base and may have a relatively shorter shelf life compared to ointments. 3.3.9. Herbal oils These are suspensions or solutions of herbal materials in an oily vehicle. Infused oils are often called macerated oils, and should not be confused with essential oils, which are aromatic oils isolated by distilling the plant material . These preparations are normally meant for external or topical use as liniments. Some of these preparations may be meant for oral use. Herbal materials such as leaves with essential oils may normally be found incorporated in these oils . The stability and shelf life of a herbal oil depends largely on the type of oil being used in the extraction process since the stability of various essential oils differs.
  • 19. Herbal formulations 19 3.3.10 Herbal poultices and plasters Poultices are made by mashing fresh herbs, wrapping in gauze and applied to an affected area of the skin after the temperature is suitable for application. Poultices may be used externally to relax muscles or to ease minor skin eruptions, poison ivy, insect bites, superficial wounds, and inflammation. Since they are normally made from fresh herbs, they should be used immediately and cannot be stored. 3.3.11 Herbal compresses and fomentations Compresses are normally prepared from an infusion or tincture in hot or cold water by soaking a cotton cloth or gauze. Compresses may be used externally and can be either warm or cold. Cold compresses reduce inflammation and help to relieve pain. They are usually used in the treatment of sprains, contusions, strains, inflammation, headaches, and insect bites. Warm compresses are used to increase circulation to an area and to allow muscles, tendons, and ligaments to stretch. 3.3.12 Herbal syrup Herbal syrup is prepared by combining a concentrated decoction with either honey or sugar, and sometimes alcohol. The base of such syrup is a strong herbal decoction. Mixing a decoction with honey or sugar helps to thicken and preserve the decoction. This increases the shelf life of the decoction and often creates a soothing application that benefits situations such as sore throat, cough, dry irritated tissues, and digestive issues. The added sweetener can also help to increase the palatability of some herbs. The basic proportions you want to use are 2 parts herbal decoction to 1 part honey or sugar. This is called a 2:1 ratio. This means that if you start with your herbs added to 4 cups of water and simmer down the liquid to 2 cups of decoction, then you will want to add 1 cup of honey or sugar to create and adequately preserve your syrup. 3.3.13. Herbal Insect repellents It help prevent and control the outbreak of insect-borne diseases such as malaria, dengue fever, bubonic plague, river blindness and West Nile fever. Pest animals commonly serving as vectors for disease include insects such as flea, fly, and mosquito; and the arachnid tick Some insect repellents are insecticides but most simply discourage insects and send them flying or crawling away. Almost any might kill at a massive
  • 20. Herbal formulations 20 dose without reprieve, but classification as an insecticide implies death even at lower doses.Essential oil repellents can be short-lived in their effectiveness, since essential oils can evaporate completely. 3.3.14 Herbal lotion Herbal lotion is a low-viscosity topical preparation intended for application to the skin. By contrast, creams and gels have higher viscosity, typically due to lower water content. Lotions are applied to external skin with bare hands, a brush, a clean cloth, or cotton wool. 3.3.15 Herbal washers Herbal Shampoo is preparation of surfactant in suitable form liquid, solid or powder, which when used under the condition specified will remove surface grease, dirt and skin debris from the hair shaft and scalp without affecting adversely the hair, scalp or health of the user. E.g: Accacia concinna . Herbal soap is a salt of a fatty acid usually made by saponification of a fatty acid with caustic soda or a suitable base. Herbal soaps have the herbal materials incorporated in the detergent base. These herbal materials normally have an antifungal and antibacterial effect on the skin and helps in cleansing of the skin. Herbal soaps are normally meant for microbial skin conditions such as dandruff, eczema, ringworm and boils. Soaps have a relatively longer shelf-life when preservatives or antioxidants are added. 3.3.16 Herbal salves These are such a simple, effective, and useful way to take in herbal goodness. They can easily be slipped into a purse, pocket, or first aid kit. Although semi-solid at room temperature, salves soften once applied to the skin, making them less messy than oils. They also make great gifts and are an easy and approachable way to introduce newbies to the power of herbs. Plus, salves can be crafted for a wide variety of topical uses. The addition of beeswax will protect, soothe, and nourish your skin. Conclusion: Herbal products may contain a single herb or combinations of several different herbs believed to have complementary and/ or synergistic effects. Some herbal products, including many
  • 21. Herbal formulations 21 traditional medicine formulations, also include animal products and minerals. Herbal products are sold as either raw plants or extracts of portions of the plant. In addition to this, these studies also provide information of of the drug. Thus, this holds great promise for future research for the formulation of potent antidiabetic drug for the present plant.