This document discusses drug adulteration and evaluation. It defines different types of drug adulteration including unintentional adulteration due to confusion or lack of knowledge, as well as intentional adulteration such as substitution using inferior varieties or artificially manufactured substances. Evaluation of crude drugs involves assessing physical, chemical, and biological characteristics including organoleptic properties, microscopic and chemical analysis, and determining bioactivity and toxicity. Proper evaluation ensures the identity, quality and safety of crude drugs.
Drug Adulteration and evaluation of the crude drug: PharmacognosySHIVANEE VYAS
Adulteration is the practice of substituting original drugs completely or partially with similar-looking substances. The substance, when mixed is either inferior inquality with chemical and therapeutic properties. The substance, which is added with the original drug, is called adulterants.
ADULTERANTS: Adulterants are either sub-standard in verity or of the original crude drug or inferior drug or artificially prepared or other substance. That is present in the original drug, which decreases its quality. In general terms, Adulteration is the regulation of any substance either by adding or taking off anything from the original substance, which decreases the quality of that substance, maybe harming health causes a variety of adverse effects from mild to moderate to severe life-threatening responses.
This adulteration is done intentionally or unintentionally Intentional adulteration is a criminal offense and punishable offense under the act, the motive behind intentional adulteration is normally commercial and originates mainly with the intention to make a profit.
Adulteration is a practice of substituting original crude drug partially or whole with other similar looking substances but the latter is either free from or inferior in chemical and therapeutic properties. Adulteration in simple words is the debasement of an article. OR Adulteration is broadly defined as admixture or substitution of original or genuine article/ drug with inferior, defective or otherwise useless or harmful substances.
ADULTRANT : The adulterant must be some material which in both cheap and available in fairly large amounts.
Drug Adulteration and evaluation of the crude drug: PharmacognosySHIVANEE VYAS
Adulteration is the practice of substituting original drugs completely or partially with similar-looking substances. The substance, when mixed is either inferior inquality with chemical and therapeutic properties. The substance, which is added with the original drug, is called adulterants.
ADULTERANTS: Adulterants are either sub-standard in verity or of the original crude drug or inferior drug or artificially prepared or other substance. That is present in the original drug, which decreases its quality. In general terms, Adulteration is the regulation of any substance either by adding or taking off anything from the original substance, which decreases the quality of that substance, maybe harming health causes a variety of adverse effects from mild to moderate to severe life-threatening responses.
This adulteration is done intentionally or unintentionally Intentional adulteration is a criminal offense and punishable offense under the act, the motive behind intentional adulteration is normally commercial and originates mainly with the intention to make a profit.
Adulteration is a practice of substituting original crude drug partially or whole with other similar looking substances but the latter is either free from or inferior in chemical and therapeutic properties. Adulteration in simple words is the debasement of an article. OR Adulteration is broadly defined as admixture or substitution of original or genuine article/ drug with inferior, defective or otherwise useless or harmful substances.
ADULTRANT : The adulterant must be some material which in both cheap and available in fairly large amounts.
Quality control of Drugs of Natural Origin. PHARMACognosy & Phytochemistry-I ...Ms. Pooja Bhandare
Quality control of Drugs of Natural Origin PHARMACognosy & Phytochemistry-I (BP405T)Unit-I Part-3.
CONTENTS
Adulteration
Evaluation of adulteration
Morphological / Organoleptic evaluation
Microscopic evaluation
Quantitative evaluation
Physical evaluation
Chemical evaluation
Biological evaluation
Adulteration is of two types:
Indirect or Unintentional adulteration
Direct or Intentional adulteration
Intentional adulteration may be due to the following reasons
adulteration using manufactured substances
substitution using inferior commercial varieties
substitution using exhausted drugs
substitution of superficially similar inferior natural substance
adulteration using the vegetative part of the same plant
addition of toxic materials
adulteration of powders
addition of synthetic principles
Evaluation of Crude Drugs
1. ORGANOLEPTIC EVALUATION
2. MICROSCOPICAL EVALUATION
Stomatal index Vein-islet number
Veinlet termination number
Palisade ratio
Quantitative Microscopy (Lycopodium Spore Method)
3.CHEMICAL EVALUATION
4. Physical Evaluation
I. Solubility
II. Optical Rotation
III. Refractive Index
III. Specific Gravity
IV Viscosity
V. Melting Point
VI. Moisture Content
VII. Ultraviolet Light
VIII. Ash Values
Total ash
Acid-insoluble ash
The water-soluble ash
IX. Extractive Values
X. Foreign Organic Matters
5. BIOLOGICAL EVALUATION
Toxicity
Oxytocic activity
Microbiological assays
Adulteration of crude drugs.
Sometimes original crude drugs are substituted with false or similar looking substances, which may be termed as Adulteration of crude drugs.
Many herbal medicinal products have been found to contain synthetic prescription drugs as chemical adulterants.
This is become evident by the number of toxicity cases and adverse reactions reported in which casualties were reported via analytical techniques that detected the presence of chemical adulterants in them, which could be responsible for their toxicity.
The adulteration of herbal medicinal products with synthetic drugs continues to be a serious problem for regulatory agencies.
The quality control standards of various medicinal plants used in indigenous system of medicine are becoming more relevant today in view of commercialization of formulations based on medicinal plants.
For standardization and quality assurance purposes, following 3 attributes are desirable i) Authenticity, ii) Purity and iii) Assay.
Authenticity relates to proving that the material is true.
Authentication in itself involves many parameters including gross morphology, microscopy, chemical analysis and DNA fingerprinting.
Purity pertains to evaluating that there are no adulterants present in the plant material.
Assay part of standardization is chemical and biological profiling which could assess the chemical effects.
What is Adulteration?
Adulteration is a process/practice of substituting the original drug/herb with completely or partially similar looking substance.
The substance may be inferior in quality or may be therapeutically inactive.
What is Deterioration?
It is the process of degradation or destruction of herbs which leads to loss of therapeutic activity of the drug/herb.
Deterioration & Adulteration are inter-related and deterioration is the main effect of adulteration.
Adulteration is classified into 2 types:
Intentional Adulteration:
As the name itself indicates the intentional adulteration is the process where the substitution of drug/herb is done in full awareness this type of adulteration is commonly done by suppliers/manufacturers.
Un-intentional Adulteration:
This is the second type of adulteration where the substitution of drug/ herbs happens without the knowledge of manufacturer/supplier.
Reasons for Intentional adulteration:
1. Due to high prices of original herb/ drugs.
2. Due to lack of availability of the drug/herbs.
3. To earn more profits by substituting the herbs by the herb of lesser price.
Types of Intentional adulteration:
1. Substitution with inferior varieties.
2. Adulteration by artificially manufactured substance.
3. Usage of vegetative part of same plant.
4. Substitution with superficially similar but cheaper natural drug substance.
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.
Role of Markers in Standardization of Herbal ProductsDr-Jitendra Patel
In this Power Point Presentation the viewer will be able to know the the different markers present naturally in herbal materials. These markers may be genitally, chemically and biochemically. How markers play major role during identification, authentication, quality control, quality assurance and determination of safety and efficacy of particular medicinal plant.
Portion covered:
1. Role of markers in standardization of herbal products
2. Factor influencing identification and quality of herbal Drugs
3. Meaning of Standardization
4. Types of Markers
5. Molecular or DNA Markers
6. Chemical Markers
7. Biochemical Markers
adulteration in herbal crude drug.
Adulteration is the act of making food or drugs of poor quality by adding some other substances to them. Consumer movement aims to protect and help customers from adulteration.
Intentional Adulteration- When substances that resemble the ingredients of the food are added to it in order to increase its weight and profit. ...
Incidental Adulteration- Incidental adulteration happens as a result of carelessness when handling food.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Adulteration of Crude Drug and Evaluation Methods Vandana Janghel
Different factor and cause of adulteration with common examples, different types of adulteration with examples, different types of quality control methods for detection of adulteration (physical , chemical, biological, morphological and microscopic methods of detection of adulterstion with examples of each evaluation parameter)
Quality control of Drugs of Natural Origin. PHARMACognosy & Phytochemistry-I ...Ms. Pooja Bhandare
Quality control of Drugs of Natural Origin PHARMACognosy & Phytochemistry-I (BP405T)Unit-I Part-3.
CONTENTS
Adulteration
Evaluation of adulteration
Morphological / Organoleptic evaluation
Microscopic evaluation
Quantitative evaluation
Physical evaluation
Chemical evaluation
Biological evaluation
Adulteration is of two types:
Indirect or Unintentional adulteration
Direct or Intentional adulteration
Intentional adulteration may be due to the following reasons
adulteration using manufactured substances
substitution using inferior commercial varieties
substitution using exhausted drugs
substitution of superficially similar inferior natural substance
adulteration using the vegetative part of the same plant
addition of toxic materials
adulteration of powders
addition of synthetic principles
Evaluation of Crude Drugs
1. ORGANOLEPTIC EVALUATION
2. MICROSCOPICAL EVALUATION
Stomatal index Vein-islet number
Veinlet termination number
Palisade ratio
Quantitative Microscopy (Lycopodium Spore Method)
3.CHEMICAL EVALUATION
4. Physical Evaluation
I. Solubility
II. Optical Rotation
III. Refractive Index
III. Specific Gravity
IV Viscosity
V. Melting Point
VI. Moisture Content
VII. Ultraviolet Light
VIII. Ash Values
Total ash
Acid-insoluble ash
The water-soluble ash
IX. Extractive Values
X. Foreign Organic Matters
5. BIOLOGICAL EVALUATION
Toxicity
Oxytocic activity
Microbiological assays
Adulteration of crude drugs.
Sometimes original crude drugs are substituted with false or similar looking substances, which may be termed as Adulteration of crude drugs.
Many herbal medicinal products have been found to contain synthetic prescription drugs as chemical adulterants.
This is become evident by the number of toxicity cases and adverse reactions reported in which casualties were reported via analytical techniques that detected the presence of chemical adulterants in them, which could be responsible for their toxicity.
The adulteration of herbal medicinal products with synthetic drugs continues to be a serious problem for regulatory agencies.
The quality control standards of various medicinal plants used in indigenous system of medicine are becoming more relevant today in view of commercialization of formulations based on medicinal plants.
For standardization and quality assurance purposes, following 3 attributes are desirable i) Authenticity, ii) Purity and iii) Assay.
Authenticity relates to proving that the material is true.
Authentication in itself involves many parameters including gross morphology, microscopy, chemical analysis and DNA fingerprinting.
Purity pertains to evaluating that there are no adulterants present in the plant material.
Assay part of standardization is chemical and biological profiling which could assess the chemical effects.
What is Adulteration?
Adulteration is a process/practice of substituting the original drug/herb with completely or partially similar looking substance.
The substance may be inferior in quality or may be therapeutically inactive.
What is Deterioration?
It is the process of degradation or destruction of herbs which leads to loss of therapeutic activity of the drug/herb.
Deterioration & Adulteration are inter-related and deterioration is the main effect of adulteration.
Adulteration is classified into 2 types:
Intentional Adulteration:
As the name itself indicates the intentional adulteration is the process where the substitution of drug/herb is done in full awareness this type of adulteration is commonly done by suppliers/manufacturers.
Un-intentional Adulteration:
This is the second type of adulteration where the substitution of drug/ herbs happens without the knowledge of manufacturer/supplier.
Reasons for Intentional adulteration:
1. Due to high prices of original herb/ drugs.
2. Due to lack of availability of the drug/herbs.
3. To earn more profits by substituting the herbs by the herb of lesser price.
Types of Intentional adulteration:
1. Substitution with inferior varieties.
2. Adulteration by artificially manufactured substance.
3. Usage of vegetative part of same plant.
4. Substitution with superficially similar but cheaper natural drug substance.
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.
Role of Markers in Standardization of Herbal ProductsDr-Jitendra Patel
In this Power Point Presentation the viewer will be able to know the the different markers present naturally in herbal materials. These markers may be genitally, chemically and biochemically. How markers play major role during identification, authentication, quality control, quality assurance and determination of safety and efficacy of particular medicinal plant.
Portion covered:
1. Role of markers in standardization of herbal products
2. Factor influencing identification and quality of herbal Drugs
3. Meaning of Standardization
4. Types of Markers
5. Molecular or DNA Markers
6. Chemical Markers
7. Biochemical Markers
adulteration in herbal crude drug.
Adulteration is the act of making food or drugs of poor quality by adding some other substances to them. Consumer movement aims to protect and help customers from adulteration.
Intentional Adulteration- When substances that resemble the ingredients of the food are added to it in order to increase its weight and profit. ...
Incidental Adulteration- Incidental adulteration happens as a result of carelessness when handling food.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
Adulteration of Crude Drug and Evaluation Methods Vandana Janghel
Different factor and cause of adulteration with common examples, different types of adulteration with examples, different types of quality control methods for detection of adulteration (physical , chemical, biological, morphological and microscopic methods of detection of adulterstion with examples of each evaluation parameter)
Similar to Drug adulteration and evaluation - .pptx (20)
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2. Drug Adulteration
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.
Inferiority is a natural substandard condition (e.g. where a crop is taken whose natural constituent is below the
minimum standard for that particular drug) which can be avoided by more careful selection of the plant
material.
Spoilage is a substandard condition produced by microbial or other pest infestation, which makes a product
unfit for consumption, which can be avoided by careful attention to the drying and storage conditions.
Deterioration is an impairment of the quality or value of an article due to destruction or abstraction of valuable
constituents by bad treatment or to the deliberate extraction of the constituents and the sale of the residue as the
original drugs.
3. • Admixture is the addition of one article to another through accident,
ignorance or carelessness.
• Sophistication is the deliberate addition of spurious or inferior material
with intent to defraud ; such materials are carefully produced and may
appear at first sight to be genuine.
• Substitution is the addition of an entirely different article in place of that
which is required.
4. Types of Adulterants
Unintentional adulteration may be due to the following reasons:
1. confusion in vernacular names between indigenous systems of medicine and local dialects
2. lack of knowledge about the authentic plant
3. nonavailability of the authentic plant
4. similarity in morphology and or aroma
5. careless collection
6. other unknown reasons
5. Intentional Adulteration
Intentional adulteration may be due to the following reasons:
Substitution using inferior commercial varieties
Substitution of superficially similar inferior natural substances
Substitution with artificially manufactured substances
Substitution with exhausted drugs
Adulteration using the vegetative part of the same plant
Addition of toxic materials
Adulteration of powders
Addition of synthetic principles
6. 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 bale fruits,
Arabian senna, obovate senna and Provence senna are used to adulterate senna, ginger being
adulterated with Cochin, African and Japanese ginger.
Japanese ginger Zingiber officinale
7. 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.
E.g. Ailanthus leaves are substituted for belladonna, senna, etc. saffron admixed with safflower; clove stalks and
mother cloves with cloves; peach kernel oil used for olive oil and Japan wax for beeswax are few examples for
this type of adulteration.
Saffron safflower Japan wax beeswax
8. Substitution with artificially manufactured substances
To provide the general form and appearance of various drugs, some materials are artificially manufactured and
are used as substitute of the original one.
E.g. Compressed chicory in place of coffee, paraffin wax after yellow coloration substituted for bees wax, bass
wood in place of Nutmeg.
Compressed chicory Coffee Bass wood Nutmeg
9. Substitution with exhausted drugs
• Here the same plant material is mixed which is having no active medicinal components as they
have already been extracted out. This practice is most common in case of volatile oil containing
materials like clove, fennel, coriander etc.
10. 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, the lower plants like mosses, liverworts and epiphytes growing on bark
portion are mixed with cascara or cinchona. Excessive number of stems in drugs like lobelia,
stramonium, etc. are few examples for this type of adulteration.
• liverworts epiphytes
11. 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 asafoetida, lead
shot in opium, amber-coloured glass pieces in colophony, barium sulphate to silver grain cochineal
and manganese dioxide to black grain cochineal, are few examples in this adulteration.
silver grain black grain colophony
12. 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.
• olive stones gentian red sanders wood
13. 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.
14. Evaluation of crude drugs
• The evaluation of crude drugs involves the assessment of the physical, chemical, and biological
characteristics of plant, animal, or mineral substances before they are further processed into
pharmaceuticals or herbal remedies. Here are some key aspects of the evaluation process:
Organoleptic Evaluation:
Color: Check for the color of the crude drug, as it can indicate the presence of specific compounds.
Odor: Assess the characteristic smell of the material.
Taste: Evaluate the taste, if applicable.
Macroscopic Evaluation:
Size and Shape: Examine the size and shape of the crude drug.
Texture: Assess the texture, noting any peculiarities or irregularities.
Foreign Matter: Look for any foreign materials like dirt, stones, or other impurities.
15. Microscopic Evaluation:
Cellular Structure: Examine the cellular structures using a microscope to identify plant tissues or other
components.
Starch Grains, Trichomes, etc.: Identify specific microscopic features that are characteristic of the plant or
substance.
Chemical Evaluation:
Chemical Constituents: Determine the presence of specific chemical compounds using qualitative and
quantitative analysis methods.
Moisture Content: Assess the moisture content, as it can affect the stability and quality of the crude drug.
Ash Content: Measure the ash content to evaluate the inorganic material present.
Physicochemical Properties:
Solubility: Determine the solubility of the crude drug in different solvents.
pH: Measure the pH of the crude drug to assess its acidity or alkalinity.
16. Biological Evaluation:
Bioactivity: Conduct tests to determine the biological activity of the crude drug, such as antimicrobial or anti-
inflammatory properties.
Toxicity: Evaluate the toxicological profile to ensure safety for human use.
Authentication:
Botanical or Source Authentication: Confirm the identity of the plant or substance using taxonomic methods.
Geographical Authentication: Determine the origin of the crude drug, as it may influence its quality.
Quality Control:
Standardization: Establish quality standards for the crude drug based on the desired therapeutic compounds.
Storage and Handling: Ensure proper storage conditions to maintain the integrity of the crude drug.