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Quality Control & Standardization Of Herbals
Role of Chemical & Biological Marker in
Standardization of Herbal Products
By
Kaushal Kumar
TABLE OF CONTENTS
01 02 03 04
Introduction Marker Types Application
Introduction
Increased herbal medicines use and lack of effective regulatory
control, the safety of herbal medicines has become a key priority issue.
Herbal drug technology is used for converting botanical materials into
medicines, where standardization and quality control with proper
integration of modern scientific techniques and traditional knowledge is
important.
According to regulatory guidelines and pharmacopoeias macroscopic
and microscopic evaluation and chemical profiling of the botanical
materials is used for quality control and standardization.
The use of chromatographic techniques and marker compounds to
standardize botanical preparations has limitations because of their
variable sources and chemical complexity.
Marker compounds may serve to calculate the number of active components of
the herbal drug in the preparation or the finished product. Markers are used at
various stages of the development and manufacturing of herbal medicine like
authentication and differentiation of species, collecting and harvesting, quality
evaluation and stability assessment, diagnosis of intoxication, and detection of
lead compounds.
Or
Marker compounds are the pure and single isolated chemical constituents
within a crude drug that confirms the exact botanical identity of that starting
material or the crude drug. Marker compounds are of interest for quality control
purposes and they may or may not contribute to the therapeutic activity.
Marker Compounds
Selection of chemical markers is crucial for the quality control of herbal
medicines, including authentication of genuine species, harvesting the best
quality raw materials, evaluation of post harvesting handling, assessment of
intermediates and finished products, and detection of harmful or toxic
ingredients.
Chemical fingerprinting has been demonstrated to be a powerful technique for
the quality control of herbal medicines.
According to regulatory guidelines and pharmacopoeias macroscopic and
microscopic evaluation and chemical profiling of the botanical materials is used
for quality control and standardization
Role of Markers
Herbal medicinal products and dietary supplements that people take to improve their
health are sold as tablets, powders, capsules, teas, extracts and fresh or dried plants.
Correct identification and quality assurance of the starting materials is therefore, an
essential requirement to ensure reproducible quality of herbal medicine which contributes
to its safety and efficacy.
 Type of Markers
► DNA Markers
► Chemical Markers
► Biochemical Markers
Type of Markers
DNA markers are the most widely used type of marker mainly due to their
abundance. DNA markers are unlimited in number and are not affected by
environmental factors, age and physiological conditions of the plant.
DNA can be extracted from fresh or dried plant tissue hence, the physical form of
the sample for assessment does not restrict detection.
 Application
→ Genetic Variation → Authentication of Medicinal Plants
→ Medicinal Plant Breeding → Herbal Drug Technology
→ Food & Nutraceuticals → New Pharmacognostic Tools
DNA Markers
Biochemical markers are either proteins or isozymes. Isozymes, also known as
Allozymes, are enzymes that are functionally similar but differ from each other in the
location, structure, net charge, electrophoretic mobility, types of activators and
inhibitors and heat stability.
The isozymes pattern has been used in many population genetic studies including
measurement of outcrossing rates, sub-population structure.
These are particularly valuable to distinguish closely related species and therefore,
useful to study diversity and identification of crops.
Eg. The Isozymes pattern of glucose 6 phosphate dehydrogenase has been used
for the identification of Eclipta prostrate (False daisy).
Biochemical Markers
The quantity of a chemical marker can be an indicator of the quality of an herbal
medicine. The study of chemical markers is applicable to many research areas,
including authentication of genuine species, search for new resources or substitutes
of raw materials, optimization of extraction and purification methods, structure
elucidation and purity determination.
Srinivasan proposed the following four categories-
 Active Principle (Possess known clinical activities)
 Active Markers (Contribute to clinical efficacy)
 Analytical Markers (No clinical or pharmacological activities)
 Negative Markers (demonstrate allergenic or toxic properties)
Chemical Markers
 Identification of adulterants
 Differentiation of herbal medicines with multiple sources
 Determination of the best harvesting time
 Confirmation of collection sites
 Assessment of processing methods
 Quality evaluation of herbal parts
 Stability test of proprietary products
 Diagnosis of herbal intoxication
 Determination of Lead compounds for new drug discovery
 Identification and quantitative determination of proprietary products
Application of Chemical Markers
THANKS!
Do you have any questions?
easyconceptkaushal@gmail.com
+91 9546688666

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Role of chemical & biological marker.pptx

  • 1. Quality Control & Standardization Of Herbals Role of Chemical & Biological Marker in Standardization of Herbal Products By Kaushal Kumar
  • 2. TABLE OF CONTENTS 01 02 03 04 Introduction Marker Types Application
  • 3. Introduction Increased herbal medicines use and lack of effective regulatory control, the safety of herbal medicines has become a key priority issue. Herbal drug technology is used for converting botanical materials into medicines, where standardization and quality control with proper integration of modern scientific techniques and traditional knowledge is important. According to regulatory guidelines and pharmacopoeias macroscopic and microscopic evaluation and chemical profiling of the botanical materials is used for quality control and standardization. The use of chromatographic techniques and marker compounds to standardize botanical preparations has limitations because of their variable sources and chemical complexity.
  • 4. Marker compounds may serve to calculate the number of active components of the herbal drug in the preparation or the finished product. Markers are used at various stages of the development and manufacturing of herbal medicine like authentication and differentiation of species, collecting and harvesting, quality evaluation and stability assessment, diagnosis of intoxication, and detection of lead compounds. Or Marker compounds are the pure and single isolated chemical constituents within a crude drug that confirms the exact botanical identity of that starting material or the crude drug. Marker compounds are of interest for quality control purposes and they may or may not contribute to the therapeutic activity. Marker Compounds
  • 5. Selection of chemical markers is crucial for the quality control of herbal medicines, including authentication of genuine species, harvesting the best quality raw materials, evaluation of post harvesting handling, assessment of intermediates and finished products, and detection of harmful or toxic ingredients. Chemical fingerprinting has been demonstrated to be a powerful technique for the quality control of herbal medicines. According to regulatory guidelines and pharmacopoeias macroscopic and microscopic evaluation and chemical profiling of the botanical materials is used for quality control and standardization Role of Markers
  • 6. Herbal medicinal products and dietary supplements that people take to improve their health are sold as tablets, powders, capsules, teas, extracts and fresh or dried plants. Correct identification and quality assurance of the starting materials is therefore, an essential requirement to ensure reproducible quality of herbal medicine which contributes to its safety and efficacy.  Type of Markers ► DNA Markers ► Chemical Markers ► Biochemical Markers Type of Markers
  • 7. DNA markers are the most widely used type of marker mainly due to their abundance. DNA markers are unlimited in number and are not affected by environmental factors, age and physiological conditions of the plant. DNA can be extracted from fresh or dried plant tissue hence, the physical form of the sample for assessment does not restrict detection.  Application → Genetic Variation → Authentication of Medicinal Plants → Medicinal Plant Breeding → Herbal Drug Technology → Food & Nutraceuticals → New Pharmacognostic Tools DNA Markers
  • 8. Biochemical markers are either proteins or isozymes. Isozymes, also known as Allozymes, are enzymes that are functionally similar but differ from each other in the location, structure, net charge, electrophoretic mobility, types of activators and inhibitors and heat stability. The isozymes pattern has been used in many population genetic studies including measurement of outcrossing rates, sub-population structure. These are particularly valuable to distinguish closely related species and therefore, useful to study diversity and identification of crops. Eg. The Isozymes pattern of glucose 6 phosphate dehydrogenase has been used for the identification of Eclipta prostrate (False daisy). Biochemical Markers
  • 9. The quantity of a chemical marker can be an indicator of the quality of an herbal medicine. The study of chemical markers is applicable to many research areas, including authentication of genuine species, search for new resources or substitutes of raw materials, optimization of extraction and purification methods, structure elucidation and purity determination. Srinivasan proposed the following four categories-  Active Principle (Possess known clinical activities)  Active Markers (Contribute to clinical efficacy)  Analytical Markers (No clinical or pharmacological activities)  Negative Markers (demonstrate allergenic or toxic properties) Chemical Markers
  • 10.  Identification of adulterants  Differentiation of herbal medicines with multiple sources  Determination of the best harvesting time  Confirmation of collection sites  Assessment of processing methods  Quality evaluation of herbal parts  Stability test of proprietary products  Diagnosis of herbal intoxication  Determination of Lead compounds for new drug discovery  Identification and quantitative determination of proprietary products Application of Chemical Markers
  • 11. THANKS! Do you have any questions? easyconceptkaushal@gmail.com +91 9546688666