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. 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

2. CONTENTS Definition Purpose of monograph
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

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.

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.

5. PURPOSE OF THE MONOGRAPHS

6. The purpose of the monographs is to:
Provide scientific information on the safety, efficacy, and quality
control/ quality assurance of widely used medicinal plant.
Provide models to assist Member States in developing their own
monographs 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 have
an interest in traditional medicines (patient, prescriber,
pharmacist, manufacturer, health authority, medicines regulatory
body) against medicine of poor quality.

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

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

9. THERAPEUTIC MONOGRAPH
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

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

11. IMPORTANCE OF CONTENT OF
THE MONOGRAPHS

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.

13. 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

14. Each medicinal plant and the specific plant part used (the drug)
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.

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

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

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.

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.

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.

20. INTRODUCTION TO VARIOUS
MONOGRAPHS AND GUIDLINES

21. Ayurvedic Pharmacopoeia of India
British Herbal Pharmacopoeia
American Herbal Pharmacopeia
Japanese Herbal Pharmacopoeia
WHO Monographs
EMEA Monographs
ESCOP 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 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.

24. Volume No. of monographs
Part 1
Volume
No. of monographs 1 80 2 78 3
100 4 68 5 84
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.
Deals with formulation.

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

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 1990
1996
84 monographs
169 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.

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

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.

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 rhizomes
Chaste tree fruit
Cramp bark
Valerian root
Ginko leaf
Echinacea purpurea root

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.
VOLUME
YEAR OF PUBLICATION
NO. OF MONOGRAPHS 1
1999 28 2
2001 31

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

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 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.

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

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

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 EMEA
Executive Director
Secretariat
The Management Board

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

46. COMPARISION

47. Commercial source & handling
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

48. API
BHP
AHP
JHP
WHO
EMEA
ESCOP
Medicinal Values  
Pharmacology
Contraindications
Warnings
Precautions
Adverse reactions
Posology
References
Clinical studies
Regulatory guidelines
from other countries

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

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.

51. REFERENCES

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 2006
Journal of American Botanical Council, 1997, issue no. 40, pg 30
World health organization, Quality Controls Methods for Medicinal Plant Materials. Geneva AITBS Publisher and Distributors, Delhi2002;8-70.