Presentation is loading. Please wait.

Presentation is loading. Please wait.

COMPARATIVE STUDY AND IMPORTANCE OF MONOGRAPHS OF STANDARDS OF MEDICINAL PLANT AND THEIR PARTS FOR HERBAL MEDICINAL PRODUCT PREPARED BY :GUIDED BY : MITALI.

Similar presentations


Presentation on theme: "COMPARATIVE STUDY AND IMPORTANCE OF MONOGRAPHS OF STANDARDS OF MEDICINAL PLANT AND THEIR PARTS FOR HERBAL MEDICINAL PRODUCT PREPARED BY :GUIDED BY : MITALI."— Presentation transcript:

1 COMPARATIVE STUDY AND IMPORTANCE OF MONOGRAPHS OF STANDARDS OF MEDICINAL PLANT AND THEIR PARTS FOR HERBAL MEDICINAL PRODUCT PREPARED BY :GUIDED BY : MITALI V. SHRIMANKERDR. N M PATEL. M.PHARM(PRINCIPAL,HOD) (3rd SEMESTER) (Department of Pharmacognosy and Phytochemistry) SHRI B. M. SHAH COLLEGE OF PHARMACEUTICAL EDUCATION AND RESEARCH. MODASA 1

2 CONTENTS  Monograph introduction  Definition  Purpose of monograph  Importance of content of monograph  Introduction of various herbal monographs and guidelines  Comparative study of various standards  Conclusion  References 2

3 DEFINITION  A monograph is a work of research or literature written about a single, specific subject. It is primarily written by experts in a particular field of study for others in that same field of study. The language and information contained in a monograph is specialized.  The establishing of a set of standards which together define the identity, purity and potency of a particular medicine. 3

4 Herbal monograph  Herbal monographs in national pharmacopoeias and other authorative documents play an important role in the authentication of herbal materials.  In this context a monograph is a document that defines a botanical drug and provides information that allows for its proper identification.  The herbal monographs give a basic description of the herb, and list its chemical constituents, actions, clinical uses and recommended dosage. 4

5 PURPOSE OF THE MONOGRAPHS PURPOSE OF THE MONOGRAPHS 5

6 The purpose of the monographs is to: Provide scientific information on the safety, efficacy, and quality Provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plant. control/ quality assurance of widely used medicinal plant. Provide models to assist Member States in developing their own Provide models to assist Member States in developing their own monographs or formularies for these or other herbal medicines. monographs or formularies for these or other herbal medicines. Facilitate information exchange among Member States. Facilitate information exchange among Member States. The goal of the monograph project is to protect those who have The goal of the monograph project is to protect those who have an interest in traditional medicines (patient, prescriber, an interest in traditional medicines (patient, prescriber, pharmacist, manufacturer, health authority, medicines regulatory pharmacist, manufacturer, health authority, medicines regulatory body) against medicine of poor quality. body) against medicine of poor quality. 6

7 TYPES OF MONOGRAPH Herbal Monograph Standards monograph Therapeutic monograph Combined monograph 7

8 Botanical features Distribution Identity tests Purity requirements Chemical assay Chemical constituents Example: USP Standards Monographs STANDARDS MONOGRAPH 8

9 Definition Of The Plant Drug Clinical applications Pharmacology Contraindications Warnings Precautions Potential adverse reactions Posology ( Form of administration, Duration of use ) Examples: ESCOP ( The European Scientific Cooperative On Phytotherapy ) monographs THERAPEUTIC MONOGRAPH 9

10 Standard monograph + Therapeutic monograph Examples: WHO (World Health organization) monographs AHP (American Herbal Pharmacopeia) monographs COMBINED MONOGRAPH 10

11 IMPORTANCE OF CONTENT OF THE MONOGRAPHS 11

12  DEFINITION Definition section provides the Latin binomial pharmacopoeial name, the most important criterion in quality assurance.  SYNONYMS AND VERNACULAR NAMES Synonyms and Selected vernacular names, are those names used in commerce or by local consumers. The vernacular names listed are a selection of names from individual countries worldwide, in particular from areas where the medicinal plant is in common use. 12

13  DESCRIPTION A detailed botanical description (under Description) is intended for quality assurance at the stages of production and collection.  GEOGRAPHICAL DISTRIBUTION Geographical distribution included here to provide additional quality assurance information.  Macroscopy  Microscopy 13

14  MAJOR CHEMICAL CONSTITUENTS Each medicinal plant and the specific plant part used (the drug) contain active or major chemical constituents with a characteristic profile that can be used for chemical quality control and quality assurance.  IDENTITY, PURITY AND STRENGTH Under the heading “Identification” tests are provided as an aid to identification and are described in their respective monographs. It includes Foreign Matter and Quantitative tests. 14

15 The quantitative tests Total ash Acid-insoluble ash Water-soluble ash, Alcohol-soluble extractive Water- soluble extractive Ether-soluble extractive Moisture content Volatile oil content Bitterness valves 15

16  CHROMATOGRAPHIC AND SPECTROSCOPIC EVALUATION TLC, HPTLC, HPLC methods will provide qualitative and quantitative information about the main active constituents present in the crude drug 16

17  PHARMACOLOGY Pharmacon + Logos Drug Discourse in It is the science of the drug that deals with the exogenously administered chemical molecules with living system. It is important as it is relevant to effective and safe use for medicinal plant.  CLINICAL STUDY To generate the optimum use of the drug. It includes pharmacodynemic and pharmacokinetic study. It is important for the evaluation of efficacy and safety of drug and comparative trials with other form of treatment. 17

18  TOXICOLOGY Important for the poisonous plant. It includes the study of adverse effect of drugs as the same substance can be a drug or a poison depending on the dose.  SAFETY If no specific toxicity is reported, it is considered to be safe in the dose traditionally used. 18

19  ADVERSE DRUG REACTION It give the information about any change which is suspected to be due to drug, occurs at doses normally used in man and indicates caution in the future use of the same drug. ADR may develop promptly or after prolonged medication or even after stopage of the drug. 19

20 20

21 Ayurvedic Pharmacopoeia of India British Herbal Pharmacopoeia American Herbal Pharmacopeia Japanese Herbal Pharmacopoeia WHO Monographs EMEA Monographs ESCOP guidelines for herbal medicinal products 21

22 22

23 AYURVEDIC PHARMACOPOEIA OF INDIA  It is the legal document of standards for the quality of Ayurvedic drugs and the substance include therein. (Under the Drug & Cosmetic act, 1940)  It was published in 1989  API has worked out monographs on the basis of genuine and authentic drug samples approved by the physician, manufacturing experts, and other expertise on the subject. 23

24 Part 2 : Vol 1 Vol 2  These all monographs deals with the pharmacognostical, chemical and ayurvedic standards of the plant drugs which are used in Ayurveda. VolumeNo. of monographs Part 1 Deals with formulation. 24

25 Plant examples : Piper longum Piper nigrum Zanthoxylum alatum Zingiber officinale Occimum sanctum 25

26 26

27 BRITISH HERBAL PHARMACOPOEIA  The UK founded British Herbal Medical Association (BHMA) in 1964 to advance the science and practice of herbal medicines in order to ensure its statutory recognition.  First British Herbal Pharmacopoeia (BHP) was published by BHMA in 1971 giving monographs and quality control tests for some of the common herbs and herbal products in the UK,  Revised in monographs 169 monographs 27

28  In 1992 BHMA published a companion British Herbal Compendium, Volume I, which gives therapeutic monographs on the same 84 herbs.  BHP mainly paid attention on developing TLC techniques for comperitive identification of new botanical drugs. 28

29 Plant examples : Aniseed Asafoetida Birch leaf Catechu Cayanne pepper Cehery seed Clove Devil Clove Aloe Garlic 29

30 30

31 JAPANEES HERBAL PHARMACOPOEIA  JSHM published in October 1993 is now available.  JSHM monographs on: 248 herbal medicines 165 from pharmacopoeia of Japan 83 from Japanese herbal medicine codex (JSHM)  In their Appendix section JSHM mentions that, contents of crude drugs given under description are given for information, and should not be taken as indicating standards for conformity. 31

32 32

33 AMERICAN HERBAL PHARMACOPOEIA  "The primary goal of the AHP is to produce authoritative herbal monographs containing accurate, critically reviewed information on botanicals which can provide guidance in the appropriate use of herbal therapeutics."  The American Herbal Pharmacopoeia began developing qualitative and therapeutic monographs in 1994, and intends to produce 300 monographs on botanicals, including many of the Ayurvedic, Chinese and Western herbs.  The AHP monographs are combined monographs; they include much of the standard definitional and analytical information found in conventional pharmacopeial monographs on standards, plus therapeutic and clinical information. 33

34 Plant examples : Ashwagandha root Astragalus root Bilberry fruit Black cohosh rhizomes Chaste tree fruit Cramp bark Valerian root Ginko leaf Echinacea purpurea root 34

35 35

36 W.H.O. MONOGRAPHS  WHO has offered a small document with an objective to provide recommended general test methods and general limits for contaminants in medicinal plant materials. 36 VOLUME YEAR OF PUBLICATION NO. OF MONOGRAPHS

37 Plant examples : Herba Centellae Flos Chamomillae Cortex Cinnamomi Rhizoma Coptidis Rhizoma Curcumae Longae Radix Echinaceae Herba Echinaceae Purpureae Herba Ephedrae Folium Ginkgo Radix Ginseng Radix Glycyrrhizae 37

38 38

39 ESCOP (The European Scientific Cooperative On Phytotherapy) MONOGRAPH ESCOP was founded in June Aims To advance the scientific status of phytomedicines. The publication in 1997 and 1999 of 60 Monographs on the Medicinal Uses of Plant Drugs  ESCOP monographs include recommended dosage, side effects and contraindications (if any), and other specific instruction, to help guide health professionals, industry, regulators, and patients  ESCOP monographs do not deal with quality issues; this is covered in other pharmacopeial monographs. 39

40 ESCOP Structure It has following memebers:  The board: Director of board Chairman Treasurer Honorary secretary  The Scientific Committees : Delegates from each member country of ESCOP  The Research Committee : At least one Board member and other invited individuals  The Secretariat : Honorary Secretary 40

41 Plant examples : Allium sativum Carum carvi Foeniculum vulgare Gentiana leutea Linum usitatissimum Melissa officinalis Veleriana officinalis Zingiber officinale 41

42 42

43 EMEA ( European Medicines Agency) MONOGRAPHS  The main task of the Committee is to establish Community herbal monographs.  The European Medicines Agency (EMEA) is a decentralised body of the European Union with headquarters in London.  Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. 43

44 Structure of EMEA  Executive Director  Secretariat  The Management Board 44

45 Plant examples : Anisi fructus (Aniseed, Pimpinella anisum) Anevae herba ( Oat herb, Avena sativa L.) Calendulae foe ( Calendula officinalis ) Curcuma longa L. Foeniculum vulgare 45

46 COMPARISION 46

47 APIBHPAHPJHPWHOEMEAESCOP Definition  Synonyms  Selected Vernacular names  History  Description  Plant material of interest  Geographical Distribution  Commercial source & handling  Reference Standards  General Identity Test  Microbiology  Chemical assay  Instrumental  Major chemical constituents - Phytochemicals  47

48 APIBHPAHPJHPWHOEMEAESCOP Medicinal Values  Pharmacology  Contraindications  Warnings  Precautions  Adverse reactions  Posology  References  Clinical studies  Regulatory guidelines from other countries  48

49 49 Quality Safety Efficacy WHO, American herbal pharmacopoeia, Ayurvedic pharmacopoeia of India ESCOP EMEA British herbal pharmacopoeia Japanees pharmacopoeia

50 CONCLUSION The availability of various types of herbal monographs will help fill the current need for information on quality control and safe, responsible use of herbal products. 50

51 REFERENCES 51

52 1.http://plimism.nic.in/publication c. html.http://plimism.nic.in/publication The Ayurvedic Pharmacopoeia of India, First Edition, Government of India, Ministry of Health and Family Welfare Department of Indian System of Medicine and Homoeopathy, New Delhi Journal of American Botanical Council, 1997, issue no. 40, pg 30 5.www.herbal.ahp.orgwww.herbal.ahp.org 6.http://europa.eu/agencics/commenity_agencies.htmhttp://europa.eu/agencics/commenity_agencies.htm 7.World health organization, Quality Controls Methods for Medicinal Plant Materials. Geneva AITBS Publisher and Distributors, Delhi2002; www.Bhma.info/publication?index.htmlwww.Bhma.info/publication?index.html 9.http://en.wikipedia.orghttp://en.wikipedia.org 10.www.escop.comwww.escop.com 52

53 53


Download ppt "COMPARATIVE STUDY AND IMPORTANCE OF MONOGRAPHS OF STANDARDS OF MEDICINAL PLANT AND THEIR PARTS FOR HERBAL MEDICINAL PRODUCT PREPARED BY :GUIDED BY : MITALI."

Similar presentations


Ads by Google