COMPARATIVE STUDY AND IMPORTANCE OF MONOGRAPHS OF STANDARDS OF MEDICINAL PLANT

AND THEIR PARTS FOR HERBAL MEDICINAL PRODUCT

PREPARED 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 PHARMACEUTICAL

EDUCATION AND RESEARCH. MODASA

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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

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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.

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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.

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PURPOSE OF THE MONOGRAPHSPURPOSE OF THE MONOGRAPHS

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The purpose of the monographs is to: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.

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TYPES OF MONOGRAPH

Herbal Monograph

Standards monograph

Therapeutic monograph

Combined monograph

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Botanical features   Distribution Identity tests Purity requirements Chemical assay Chemical constituents

Example: USP Standards Monographs

STANDARDS MONOGRAPH

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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

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Standard monograph + Therapeutic monograph

Examples:

WHO (World Health organization) monographs

AHP (American Herbal Pharmacopeia) monographs

COMBINED MONOGRAPH

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IMPORTANCE OF CONTENT OF THE MONOGRAPHS

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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.

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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

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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.

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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

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CHROMATOGRAPHIC AND SPECTROSCOPIC

EVALUATION

TLC, HPTLC, HPLC methods will provide qualitative

and quantitative information about the main active

constituents present in the crude drug

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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

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.

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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.

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Ayurvedic Pharmacopoeia of India

British Herbal Pharmacopoeia

American Herbal Pharmacopeia

Japanese Herbal Pharmacopoeia

WHO Monographs

EMEA Monographs

ESCOP guidelines for herbal medicinal products

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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.

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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.

Volume No. of monographs1 80

2 78

3 100

4 68

5 84

Part 1

Deals with formulation.

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Plant examples :

Piper longumPiper nigrumZanthoxylum alatumZingiber officinaleOccimum sanctum

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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 1990 1996

84 monographs

169 monographs

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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.

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Plant examples :

Aniseed Asafoetida Birch leaf Catechu Cayanne pepper Cehery seed Clove Devil Clove Aloe Garlic

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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.

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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.

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Plant examples :

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

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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.

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VOLUMEYEAR OF

PUBLICATIONNO. OF

MONOGRAPHS

1 1999 28

2 2001 31

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

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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 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.

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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

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Plant examples :

Allium sativum Carum carvi Foeniculum vulgare Gentiana leutea Linum usitatissimum Melissa officinalis Veleriana officinalis Zingiber officinale

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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.

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Structure of EMEA

Executive Director Secretariat The Management Board

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Plant examples :

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

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COMPARISION

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API BHP AHP JHP WHO EMEA ESCOP

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

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API BHP AHP JHP WHO EMEA ESCOP

Medicinal Values

Pharmacology

Contraindications

Warnings

Precautions

Adverse reactions

Posology

References

Clinical studies

Regulatory guidelines from other countries

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QualitySafety

Efficacy

WHO, American herbal pharmacopoeia, Ayurvedic pharmacopoeia of India

ESCOP EMEA

British herbal pharmacopoeiaJapanees pharmacopoeia

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.

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REFERENCES

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1. http://plimism.nic.in/publication c. html.2. www.saujanyabooks.com3. 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 2006

4. Journal of American Botanical Council, 1997, issue no. 40, pg 305. www.herbal.ahp.org6. http://europa.eu/agencics/commenity_agencies.htm7. World health organization, Quality Controls Methods for Medicinal

Plant Materials. Geneva AITBS Publisher and Distributors, Delhi2002;8-70.

8. www.Bhma.info/publication?index.html9. http://en.wikipedia.org10. www.escop.com

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