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."— Presentation transcript:
1 COMPARATIVE STUDY AND IMPORTANCE OF MONOGRAPHS OF STANDARDS OF MEDICINAL PLANT AND THEIR PARTS FOR HERBAL MEDICINAL PRODUCTPREPARED BY : GUIDED BY :MITALI V. SHRIMANKER DR. N M PATEL.M.PHARM (PRINCIPAL,HOD)(3rd SEMESTER)(Department of Pharmacognosy and Phytochemistry)SHRI B. M. SHAH COLLEGE OF PHARMACEUTICALEDUCATION AND RESEARCH. MODASA
2 CONTENTS Definition Purpose of monograph Monograph introductionDefinitionPurpose of monographImportance of content of monographIntroduction of various herbal monographs and guidelinesComparative study of various standardsConclusionReferences
3 DEFINITIONA 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.
4 Herbal monographHerbal 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.
6 The purpose of the monographs is to: Provide scientific information on the safety, efficacy, and qualitycontrol/ quality assurance of widely used medicinal plant.Provide models to assist Member States in developing their ownmonographs or formularies for these or other herbal medicines.Facilitate information exchange among Member States.The goal of the monograph project is to protect those who havean interest in traditional medicines (patient, prescriber,pharmacist, manufacturer, health authority, medicines regulatorybody) against medicine of poor quality.
7 Therapeutic monograph TYPES OF MONOGRAPHHerbal MonographTherapeutic monographCombined monographStandards monograph
9 THERAPEUTIC MONOGRAPH Definition Of The Plant DrugClinical applicationsPharmacologyContraindicationsWarningsPrecautionsPotential adverse reactionsPosology ( Form of administration, Duration of use )Examples: ESCOP (The European Scientific Cooperative On Phytotherapy) monographs
10 COMBINED MONOGRAPHStandard monograph + Therapeutic monograph Examples: WHO (World Health organization) monographs AHP (American Herbal Pharmacopeia) monographs
12 DEFINITIONDefinition section provides the Latin binomial pharmacopoeialname, the most important criterion in quality assurance.SYNONYMS AND VERNACULAR NAMESSynonyms and Selected vernacular names, are those names used incommerce or by local consumers. The vernacular names listed are aselection of names from individual countries worldwide, in particularfrom areas where the medicinal plant is in common use.
13 A detailed botanical description (under Description) is intended for quality assurance at the stages of production and collection.GEOGRAPHICAL DISTRIBUTIONGeographical distribution included here to provide additionalquality assurance information.MacroscopyMicroscopy
14 Each medicinal plant and the specific plant part used (the drug) MAJOR CHEMICAL CONSTITUENTSEach medicinal plant and the specific plant part used (the drug)contain active or major chemical constituents with a characteristicprofile that can be used for chemical quality control and qualityassurance.IDENTITY, PURITY AND STRENGTHUnder the heading “Identification” tests are provided as anaid to identification and are described in their respectivemonographs.It includes Foreign Matter and Quantitative tests.
15 The quantitative tests Total ashAcid-insoluble ashWater-soluble ash,Alcohol-soluble extractiveWater- soluble extractiveEther-soluble extractiveMoisture contentVolatile oil contentBitterness valves
16 CHROMATOGRAPHIC AND SPECTROSCOPIC EVALUATIONTLC, HPTLC, HPLC methods will provide qualitativeand quantitative information about the main activeconstituents present in the crude drug
17 PHARMACOLOGYPharmacon + LogosDrug Discourse inIt is the science of the drug that deals with the exogenouslyadministered chemical molecules with living system.It is important as it is relevant to effective and safe use formedicinal plant.CLINICAL STUDYTo generate the optimum use of the drug.It includes pharmacodynemic and pharmacokinetic study.It is important for the evaluation of efficacy and safety of drugand comparative trials with other form of treatment.
18 TOXICOLOGYImportant for the poisonous plant.It includes the study of adverse effect of drugs as the samesubstance can be a drug or a poison depending on the dose.SAFETYIf no specific toxicity is reported, it is considered to be safe in thedose traditionally used.
19 ADVERSE DRUG REACTIONIt give the information about any change which is suspected to be due todrug, occurs at doses normally used in man and indicates caution inthe future use of the same drug.ADR may develop promptly or after prolonged medication or even afterstopage of the drug.
20 INTRODUCTION TO VARIOUS MONOGRAPHS AND GUIDLINES
21 Ayurvedic Pharmacopoeia of India British Herbal PharmacopoeiaAmerican Herbal PharmacopeiaJapanese Herbal PharmacopoeiaWHO MonographsEMEA MonographsESCOP guidelines for herbal medicinal products
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 1989API 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.
24 Volume No. of monographs Part 1VolumeNo. of monographs1802783100468584Part 2 : Vol 1Vol 2These all monographs deals with the pharmacognostical, chemical and ayurvedic standards of the plant drugs which are used in Ayurveda.Deals with formulation.
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 1990199684 monographs169 monographs
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.
31 JAPANEES HERBAL PHARMACOPOEIA JSHM published in October 1993 is now available.JSHM monographs on: 248 herbal medicines165 from pharmacopoeia of Japan83 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.
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.
34 Plant examples : Ashwagandha root Astragalus root Bilberry fruit Black cohosh rhizomesChaste tree fruitCramp barkValerian rootGinko leafEchinacea purpurea root
36 W.H.O. MONOGRAPHSWHO has offered a small document with an objective to providerecommended general test methods and general limits forcontaminants in medicinal plant materials.VOLUMEYEAR OF PUBLICATIONNO. OF MONOGRAPHS11999282200131
39 ESCOP (The European Scientific Cooperative On Phytotherapy) MONOGRAPH ESCOP was founded in June 1989.Aims To advance the scientific status of phytomedicines.The publication in 1997 and 1999 of 60 Monographs on the Medicinal Uses of Plant DrugsESCOP monographs include recommended dosage, side effects and contraindications (if any), and other specific instruction, to help guide health professionals, industry, regulators, and patientsESCOP monographs do not deal with quality issues; this is covered in other pharmacopeial monographs.
40 ESCOP Structure It has following memebers: The board: Director of boardChairmanTreasurerHonorary secretaryThe Scientific Committees :Delegates from each member country of ESCOPThe Research Committee :At least one Board member and other invited individualsThe Secretariat :Honorary Secretary
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.
44 Structure of EMEAExecutive DirectorSecretariatThe Management Board
48 APIBHPAHPJHPWHOEMEAESCOPMedicinal ValuesPharmacologyContraindicationsWarningsPrecautionsAdverse reactionsPosologyReferencesClinical studiesRegulatory guidelinesfrom other countries
49 WHO, American herbal pharmacopoeia, Ayurvedic pharmacopoeia of India ESCOPEMEABritish herbal pharmacopoeiaJapanees pharmacopoeiaSafety EfficacyQualityWHO, American herbal pharmacopoeia,Ayurvedic pharmacopoeia of India49
50 CONCLUSIONThe 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.
52 http://plimism.nic.in/publication c. html. 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 2006Journal of American Botanical Council, 1997, issue no. 40, pg 30World health organization, Quality Controls Methods for Medicinal Plant Materials. Geneva AITBS Publisher and Distributors, Delhi2002;8-70.