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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.](https://image.slidesharecdn.com/astudyreportonvarioushp-230217033504-f4896df8/85/A-Study-report-on-various-HP-pptx-11-320.jpg)
A Study report on various HP.pptx
- 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 1
- 2. Index Sr. No. Contents Slide No 1. Introduction 3 2. Review 4 3. Conclusion 10 4. Reference 11 2
- 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. 3
- 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. 4
- 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. 5
- 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. 6
- 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. 7
- 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. 8
- 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. 9
- 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. 10
- 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.