Herbal pharmacopeia

1. A STUDY OF VARIOUS CHROMATOGRAPHIC TECHNIQUES IN HERBAL DRUG
ANALYSIS
Priyadarshini J. L. College of Pharmacy
Electronic Zone Building, MIDC, Hingna Road, Nagpur 440016 2021-2022
Presented By Guided By
PROJECT
Date-
Sohail S. Sheikh Dr.Mrs. Sonal P.
Motghare
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2. Index
Sr. No. Contents Slide No
1. Introduction 3
2. Review 4
3. Conclusion 10
4. Reference 11
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3.  Pharmacopoeia, literally means “drug-making”, technically is a book published by the
authority of a government or a medical or pharmaceutical society containing directions
for the
identification of medicines, shortly a legal document containing standards for medicinal
commodities.
 The modern day pharmacopoeias are strictly for standards of medicines and every
developed
country has a pharmacopoeia for their medicaments of synthetic as well as natural
origin. Some popular herbal pharmacopoeias of world are American Herbal
Pharmacopoeia (AHP), British Herbal Pharmacopoeia (BHP), Korean Herbal
Pharmacopoeia (KHP), etc.
 These monographs represent the most comprehensive and critically reviewed body of
information on herbal medicines in the English language, and serve as a primary
reference for academicians, health care providers, manufacturers, and regulators.
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4. Various Herbal Pharmacopoeias The Ayurvedic Pharmacopoeia of India
 The Ayurvedic Pharmacopoeia of India
 European Herbal Pharmacopoeia
 British Herbal Pharmacopoeia
 United States Herbal Pharmacopoeia
 Korean Herbal Pharmacopoeia
 West African Herbal Pharmacopoeia
 France Pharmacopoeia
 Germany Pharmacopoeia
 Japan Pharmacopoeia
 Chinese Pharmacopoeia
 Pharmacopoeia Commission for Indian Medicine &
Homoeopathy is an autonomous organization under
Ministry of AYUSH, Govt. of India with a primary
mandate to develop pharmacopoeial standards for
drugs/formulations used under Ayurveda, Siddha,
Unani and Homoeopathic systems of medicine.
 Monographs for 152 compound Ayurvedic
formulations are published in Ayurvedic
Pharmacopoeia of India (Part II, Volume1 to 3).
Other than API, Siddha Pharmacopoeia of India
(Volume 1 and 2), Homeopathic Pharmacopoeia of
India (Volume 1 to 6) and Unani Pharmacopoeia of
India (Volume 1 to 6) are the standards of books
available for Indian herbs.
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5. European Herbal Pharmacopoeia British Herbal Pharmacopoeia
• European pharmacopeia commission started
working since 1964 to prepare EP Editions. Since
its 5th edition, the pharmacopoeia is published in 2
volumes. Volume I contains general chapters and
monographs (eg. on dosage forms, methods of
analysis reagents), volume 2 contains all substance
monographs.
• The European Pharmacopoeia (Ph. Eur.) defines
requirements for the qualitative and quantitative
composition of medicines, the tests to be carried out
on medicines and on substances and materials used
in their production.
• The only official source of British pharmaceutical
standards Produced by the British Pharmacopoeia
Commission Secretariat of the Medicines and
Healthcare Products Regulatory Agency, and
updated annually, the British Pharmacopoeia (BP)
is the official, authoritative collection of standards
for UK medicinal substances for human and
veterinary use.
• The 2014 edition includes almost 3500 monographs
which are legally enforced by the Human Medicines
Regulations 2012.
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6. United States Herbal
Pharmacopoeia
Korean Herbal Pharmacopoeia
• The American Herbal Pharmacopoeia (AHP) was
founded in 1995 as a nonprofit educational
foundation dedicated to the advancement of
knowledge and quality of medicinal herbal products
and herbal dietary supplements.
• AHP monographs are considerably different from
most pharmacopoeial monographs, which establish
and provide guidelines for identification, purity, and
minimal quality along with the appropriate tests for
meeting these standards.
• AHP also conducts critical reviews of the available
therapeutic and safety data that exist on herbal
medicines.
• Korean Herbal Pharmacopeia has been served as
characteristics of an official standard for
description and quality of drugs which are
generally recognized to be safe and efficacious in
treatment and prevention of diseases.
• The recent KHP contains a total of 2,462 official
monographs (Part I and Part II). Part I includes;
frequently used drugs and their primary
preparations and Part II includes; crude drugs,
biological drugs, radioactive drugs, combined
preparations, additives for preparations and quasi-
drugs.
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7. West African Herbal Pharmacopoeia France Pharmacopoeia
• The AfrHP provides comprehensive, up to date
botanical, commercial and phytochemical
information on over 50 of the most important
African medicinal plants. The technical data were
made on plant samples sourced from across the
continent.
• Additional data includes; micro-morphology of the
plant material, distribution maps and TLC
chromatograms. These data are crucial for
producers, collectors and traders in medicinal
plants and extracts as well as researchers,
manufacturers and practitioners.
• The scope, quality and standard of these herbal
monographs are comparable to those prepared in
Europe, North America and Asia.
• The French Medicines Agency (Agence du
Médicament) grants marketing authorizations
based on abridged dossiers by making reference to
traditional use.
• The list of drugs with accepted traditional uses was
first published in 1985 by the Ministry of Health
and has subsequently been revised several times.
• Traditional use of approximately 200 herbal drugs
or preparations derived from these drugs has been
recognized for minor indications.
• Agency Instructions includes rules for labelling and
packaging of herbal medicinal products.
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8. Germany Pharmacopoeia Japan Pharmacopoeia
• The legal status for herbal remedies was defined by
the Medicines Act of 24 August 1976. For
finished drugs a marketing authorization is
obligatory. Herbal finished drugs have to comply
with the same criteria for quality, safety and
efficacy as all other finished drugs.
• Finished herbal drugs may be authorized for
marketing in one of three ways:
1. Evaluation and validation of old medicines.
2. Standardized marketing authorization.
3. Individual application for marketing
authorization.
• Japanese traditional medicine, as used in Japanese
society for more than a thousand years, may
be divided into folk medicine and Chinese medicine
(or Kampo medicine).
• One hundred and forty-six Kampo drugs are
registered as drugs by the Ministry of Health and
Welfare (MHW) and are included in coverage under
the National Health Insurance.
• Acceptance of Kampo drugs took place without
clinical validation studies. In 1989,
about 80% of physicians reported prescribing
Chinese medicine; traditional drugs are viewed
in Japanese society as safe.
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9. Chinese Pharmacopoeia
• Many herbal medicines have been used for hundreds of years and it is assumed in many cases that
they must work. For example, about 7000 species of plants are used in China as herbal medicines,
but only 230 of the most commonly used ones have been subject to in-depth pharmacological,
analytical and clinical studies.
• The 2000 edition of the Chinese pharmacopoeia included 784 items on traditional Chinese
medicines and 509 on Chinese patent medicines. Herbal medicines in China are normally
considered as medicinal products with special requirements for marketing.
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10. Conclusion
• The modern day herbal pharmacopoeias are strictly for standards of medicines and every
developed country has a pharmacopoeia for their medicaments of natural origin. The
monographs are consisted of general titles such as definition, production, characters,
identification test, assay, storage, labelling and impurity. The main purpose of herbal
pharmacopoeias is to produce good quality of herbal drugs for human health. Some popular
herbal pharmacopoeias of world are American Herbal Pharmacopoeia, British Herbal
Pharmacopoeia, Korean Herbal Pharmacopoeia, Ayurvedic Pharmacopoeia of India, etc.
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11. 11
Reference
1. Sunil Kumar KN. Herbal Pharmacopoeias– an overview of
international and Indian representation. Journal of Ayurvedic
and Herbal Medicine 2015; 1(3): 59-60.
2. The Ayurvedic Pharmacopoeia Of India Part – I,
Pharmacopoeia Commission for Indian Medicine &
Homoeopathy Ministry of AYUSH, Government of India,
2016, Pt.I.Vol.IX, v-xxvii
3. European Commission (1965) Council Directive 65/65/EEC
of 26 January 1965 on the approximation of provisions laid
down by Law, Regulation or Administrative Action relation to
proprietary medicinal products. Off. J., P22, 369–373
4. IARC Working Group on the Evaluation of Carcinogenic
Risks to Humans. Some Traditional Herbal Medicines, Some
Mycotoxins, Naphthalene and Styrene. Lyon
(FR): International Agency for Research on Cancer; 2002.
(IARC Monographs on the Evaluation of Carcinogenic Risks
to Humans, No. 82.) A, Introduction. Available from:
https://www.ncbi.nlm.nih.gov/books/NBK326625/
5. Food and Drug Administration (2000) Guidance for
Industry: Botanical Drug
Products, Washington DC, Center for Drug Evaluation and
Research [http://www.fda.gov/cder/guidance/index.htm]
6. Ministry of Food and Drug Safety, National Institute of
Food and Drug Safety
Evaluation, Herbal Medicinal Products Division, PARK, Ju
Young pg 5-14.
7. West African Health Organisation (WAHO) Bobo-Dioulasso
(Burkina Faso), pg no. iv-x.
8. AESGP (Association Européenne des Spécialités
Pharmaceutiques Grand Public; The Association of the
European Self-Medication Industry) (1998) Herbal Medicinal
Products in the European Union. Study Carried out on Behalf
of the European Commission, Brussels
[http://pharmacos.eudra.org/F2/pharmacos/docs/doc99/Herbal
%20Medecines%20EN.pdf]
9. Keller K. Legal requirements for the use of
phytopharmaceutical drugs in the FederalRepublic of
Germany. Journal of Ethnopharmacology 1991; 32:225–229.
10. Saito H. Regulation of herbal medicines in Japan.
Pharmacological Regulations 2000;41:515–519.
11. Chan T.Y.K. Monitoring the safety of herbal medicines.
Drug Safety. 1997; 17:209–215.