UNIT 5 Herbal Literature - Nmsby

UNIT 5REVIEW OF HERBALLITERATURECONTENT:5.1 – MONOGRAPHS5.2 – PHARMACOPOEIA5.3 – WEB BASED INFORMATIONDATABASE1

LEARNING OUTCOMEØExplain sources of references for herballiterature reviewØDescribe the distinct features of herbalmonographs, pharmacopeias, and web-basedinformation database2

HERBAL LITERATUREThree available herbal literature-Monographs-Pharmacopoeia-Web based information3

MONOGRAPH11-04-20194

MONOGRAPH A monograph is a specialist work of writingon a single subject or an aspect of a subject,usually by a single author. The term "monographia" is derived from theGreek mono (single) and grapho (to write),meaning "writing on a single subject".5

HERBAL MONOGRAPHS A modern herb monograph is a compilation or reportabout a specific herb providing detailed informationwhich is organised in a logical structure, includingbotanical and pharmaceutical information Monographs can vary in length, from a single pagesummary to a multi-page text. Published herb monographs have served an importantrole in ensuring the quality of herbal supplies by includingdetailed descriptions of their physical characteristics,particularly of dried herbs in trade.6

MALAYSIA HERBAL MONOGRAPHS Volume 1, published in 1990 by KKM Volume 2, published in 2009 by FRIM Volume 3 , published in 2013 by FRIM 20 monograph/species in each volume.7

MALAYSIA HERBAL MONOGRAPHSMalaysian Herbal Monograph 2015 published in 2015 by Institute for MedicalResearch 69 monographs 60 monographs (16 revised/update) extractedfrom MHM Volume 1-3 9 monographs are new herbal monographs8

INSTITUTION INVOLVEDInstitution involved in development of Malaysian HerbalMonograph (MHM)Ø Institute of Medical Research (IMR)Ø National Pharmaceutical Control Bureau (NPCB)Ø Forest Research Institute Malaysia (FRIM)Ø Malaysian Agriculture Research and Development Institute(MARDI)Ø Local Universities such as UKM, UPM and USM-Technical/Scientific Committee-Main Committee9

WORKFLOW IN PRODUCINGMONOGRAPHS11-04-201910

THE IMPORTANCE OF MALAYSIANHERBAL MONOGRAPHS1. Invaluable source of scientific information on herbalmedicines - Regulators, manufacturers, academia,researchers, health professionals & others2. Authorities information- Therapeutic uses of herbal medicines- Summaries of pharmacological, clinical & toxicological data3. Ensuring the quality and right raw material goes into theproduct- Guidance for authentication of plant material- Guidance for quality control profile for herbal materials andproducts (correct species & correct part )*Authentication is the most basic quality step11

USE OF THE HERBALMONOGRAPHS WHO encourages countries to provide safe andeffective traditional remedies and practices in publicand private health services The monographs are intended primarily to promoteharmonization in the use of herbal medicines withrespect to levels of safety, efficacy, and qualitycontrol The monographs will be supplemented and updatedperiodically as new information appears in theliterature, and additional monographs will beprepared.12

THE PURPOSEThe purpose of the WHO herbal monographs is to:1. provide scientific information on the safety, efficacy,and quality control/ quality assurance of widely usedmedicinal plants, in order to facilitate their appropriateuse2. provide models to assist Member States in developingtheir own monographs or formularies for these orother herbal medicines; and3. facilitate information exchange among MemberStates.13

THE CONTENTEach herbal monograph contains two parts:1. The first part - consists of pharmacopoeial summariesfor quality assurance (botanical features, distribution,identity tests, purity requirements, chemical assays, andactive or major chemical constituents)2. The second part- summarizes clinical applications,pharmacology, contraindications, warnings, precautions,potential adverse reactions, and posology14

FIRST PART CONTENTPHARMACOPOEIAL SUMMARIES FOR QUALITYASSURANCE1. Definition – provides Latin binomial pharmacopoeial name2. Synonyms and selected vernacular names - those names used incommerce or by local consumers3. Description – provides detailed botanical description intended forquality assurance at the stages of production and collection4. Plant material of interest – provides detailed description of the drugmaterial (under) is for the same purpose at the manufacturing andcommerce stages5. General identity tests, Purity tests, and Chemical assays -all normalcompendial components included under those headings in thesemonographs6. Major chemical constituents - active or major chemical constituents witha characteristic profile that can be used for chemical quality control andquality assurance15

SECOND PART CONTENT1. Dosage forms and of Medicinal uses - categorized as those usessupported by clinical data, those uses described inpharmacopoeias and in traditional systems of medicine, andthose uses described in folk medicine, not yet supported byexperimental or clinical data2. Pharmacology (both experimental and clinical)3. Contraindications such as sensitivity or allergy4. Warnings & Precautions - discussion of drug interactions,carcinogenicity, teratogenicity and special groups such aschildren and nursing mothers5. Adverse reactions6. Posology16

CONCLUSIONThe herbal monograph provides an organised set ofinformation about an individual plant, ideally givingdetails of traditional uses, constituents, actions, andresearch findings with references.A reliable herbal monograph saves a lot of time andeffort searching for evidence.17

PHARMACOPOEIA11-04-201918

PHARMACOPOEIA Derived from Greek word ‘Pharmakon’ means drug and ‘Poiea’means to make. Pharmacopoeia, pharmacopeia, or pharmacopoea literally, "drug-making’’ It is a legal and official book issued by recognized authoritiesusually appointed by Government of each country. It comprises list of pharmaceutical substances, dosage formsalong with their description and standards.19

PHARMACOPOEIA A book containing directions for the identification of samplesand the preparation of compound medicines, and published bythe authority of a government or a medical or pharmaceuticalsociety. In a broader sense it is a reference work for pharmaceuticaldrug specifications. containing a description of drugs used in current medicalpractice and noting their formulae, analytical compositionif known, physical constants, main chemical propertiesuseful for identification and mode of preparation ofcompound preparations/combination products.20

LIST OF PHARMACOPEIASa) Argentinef) Chinesek) Hungariano) Japaneses) Nordicw) Russianb) Austrian c) Belgiand) Brazilian e) Britishg) Egyptian h) Europeani) Frenchj) Germanl) Indian m) International n) Italianp) Yugoslavian q) Mexican r) Netherlandst) Polishu) Portuguese v) Rumanianx) Spanishy) Turkish z) United state.* COUNTRIES HIGHLIGHTED IN BLUE COLOUR ARE THE WELL KNOWN/RELIABLEPHARMACOPOEIA21

GENERAL CONTENT Category : as antifungal , anti bacteria, adrenalglucocorticoid Description: Physical form of the material,whether hygroscopic, odour, and indication ofpolymorphism, if applicable Identity Test: usually using equipment like IRspectrometry, TLC, HPLC, or conventionalmethod like titration, if appropriate Non-specific purity tests: such as lightabsorption, optical rotation, sulphated ash etc22

Related Substance : to identify Impurities in the drugsthat may result from manufacturing process or bydegradation of product during storage Assay: to measure the percentage content of activecompound in the product/ drugs itself Storage guidelines : considering differentgeographical atmosphere23

EXAMPLE FOR TYPES OF SUBSTANCESIN PHARMACOPOEIA MONOGRAPHS Pharmaceutical substance Dosage Forms Supplementary Information Excipient Substances of biological origin and biotechnologyetc .24

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LEARNING CHECK!!What are the differences betweenherbal monographs andpharmacopoeia?26

DISTINCT FEATURES: CONTENT à Herbal vs API PURPOSE : Herbal monographs & pharmacopoeial monographs aredifferent, Herbal monographs provide scientific information on the safety,efficacy, and quality control of widely used medicinal plants; pharmacopoeia are comprehensive scientific references for drugregulatory authorities, physicians, traditional health practitioners,pharmacists, manufacturers, research scientists and the generalpublic.27

web basedinformationdatabases11-04-201928

WEB BASED INFORMATION DATABASESWeb-based information system :Øan information system that uses Internet webtechnologies to deliver information andservices to users or other informationsystems/applications.Database - an electronic filing system :Øa collection of information organized in sucha way that a computer program can quicklyselect desired pieces of data.29

CHARACTERISTICS OF WEB BASEDDATABASE1. Global access:The internet enables worldwide access, using existinginfrastructure and standard telecommunicationsprotocols.2. Ease of use:Web browsers provide a familiar interface that is userfriendly and easily learned.3. Multiple platforms:Web-based design is not dependent on a specificcombination of hardware or software. All that is requiredis a browser and an internet connection.30

4. Cost effectiveness:Initial investment is relatively low, because the internet servesas the communication network. Users require only a browser,and web-based systems do not require powerful workstation.Flexibility is high, because numerous outsourcing options existfor development, hosting, maintenance, and system support.5. Security issues:Security is a universal issue, but internet connectivity raisesspecial concerns. These can be addressed with a combinationof good design, software that can protect the system anddetect intrusion, stringent rules for passwords and useridentification, and vigilant users and managers.6. Adaptability issues:The internet offers many advantages in terms of access,connectivity, and flexibility. Converting a traditional databasedesign to the web, however, can require design modification,additional software, and some added expense.31

MALAYSIAN HERBAL DATABASEhttp://www.globinmed.com/index.php?option com content&view article&id 80849&Itemid 10132

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PURPOSE : Herbal monographs & pharmacopoeial monographs are different, Herbal monographs provide scientific information on the safety, efficacy, and quality control of widely used medicinal plants; pharmacopoeia are comprehensive scientific references for drug regulatory a