Monographs, Pharmacopoeia PPT

MONOGRAPHS
25-12-2019V.K. VIKRAM VARMA
1

CONTENTS
• WHAT IS PHARMACOPOEIA?
• HISTORY OF PHARMACOPOEIA
• CONTENT OF PHARMACOPOEIA
• WHAT IS MONOGRAPH?
• PURPOSE OF MONOGRAPH
• TYPES OF MONOGRAPH
• IMPORTANCE OF CONTENT OF MONOGRAPH
• MONOGRAPH DEVELOPMENT PROCESS
• INDIAN PHARMACOPOEIA
• AYURVEDIC PHARMACOPOEIA
• UNNANI PHARMACOPOEIA
• SIDDHA PHARMACOPOEIA
• GERMAN HOMOEPATHIC PHARMACOPOEIA
• US PHARMACOPOEIA
• JAPANESE PHARMACOPOEIA
• BRITISH PHARMACOPOEIA
• EUROPEAN PHARMACOPOEIA
• COMPARATIVE STUDY
• CONCLUSION
• REFERENCE
2

WHAT IS A PHARMACOPOEIA??
• It is a legally binding, collection, prepared by a national or regional authority
& contains list of medicinal substances, crude drug & formulas for making
preparation from them.
3
Pharmakon
(Drug)
Poeia
(To make)
Pharmacopoeia

HISTORY OF PHARMACOPOEIA
• Persian physicians wrote Canon of Medicine of Avicenna in 1025, Abu-
Rayhan Biruni (11th century), Ibn Zuhr (12th century) and Ibn Baytar (14th
century).
• Pliny’s pharmacopoeia is considered to be the cradle of pharmacotherapy.
• Pedanius Dioscoride De Materia Medica , precursor to all modern
pharmacopoeias, and is one of the most influential herbal books in history.
4

CONTENT OF PHARMACOPOEIA
•List of drug and other
related substances
•Sources
•Description
•Tests
•Formulas for preparation
•Uses
•Doses
•Storage conditions
5

WHAT IS A MONOGRAPH?
• DEFINATION:
o A monograph is a book ,pamphlet or document that is complete in itself.
or
o A detailed written study of a single specialized subject or an aspect of it.
• Researchers publish their findings in monographs so their peers can review and
validate their findings.
6

PURPOSE OF MONOGRAPH
• Provide scientific information on the safety, efficacy, and quality control/
quality assurance of widely used medicinal plant.
• 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

TYPES OF MONOGRAPH
STANDARD
MONOGRAPH
• Botanical features
• Distribution
• Identity tests
• Purity requirements
• Chemical assay
• Chemical constituents
THERAPETUIC
MONOGRAPH
• Definition Of The Plant Drug
• Clinical applications
• Pharmacology
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Posology ( Form of administration,
Duration of use )
COMBINED
MONOGRAPH
• Standard monograph +
Therapeutic monograph
8

IMPORTANCE OF CONTENT OF
THE MONOGRAPHS
DEFINITION
o Definition section provides the Latin binomial
pharmacopoeial name, the most important
criterion in quality assurance.
SYNONYMS AND VERNACULAR NAMES
o Those names used 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.
Description
o A detailed botanical description is intended
for quality assurance at the stages of
production and collection.
 Macroscopy
 Microscopy
9

CONTD.
GEOGRAPHICAL DISTRIBUTION
o Geographical distribution included here to
provide additional quality assurance information.
MAJOR CHEMICAL CONSTITUENTS
o Each medicinal plant & 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 & quality
assurance.
IDENTITY, PURITY AND STRENGTH
o Under the heading “Identification” tests are
provided as an aid to identification and are
described in their respective monographs.
o It includes Foreign Matter & Quantitative tests.
10

CONTD.
• The quantitative tests
o Total ash
o Acid-insoluble ash
o Water-soluble ash
o Alcohol-soluble extractive
o Water- soluble extractive
o Ether-soluble extractive
o Moisture content
o Volatile oil content
o Bitterness valves
CHROMATOGRAPHIC AND
SPECTROSCOPIC EVALUATION
o TLC, HPTLC, HPLC methods will provide
qualitative & quantitative information about
the main active constituents present in the
crude drug
11

CONTD.
TOXICOLOGY
o 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
o If no specific toxicity is reported, it is
considered to be safe in the dose
traditionally used.
ADVERSE DRUG REACTION
o 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 stop age
of the drug.
12

MONOGRAPH DEVELOPMENT PROCESS
• Individual monographs are followed along with the requirements of the General Notices, general test
methods and to other information given in the General Chapters.
• A final assessment of the quality of an article is to be done on a total evaluation of compliance with all
these requirements and not in relation to only the contents of individual monographs.
• Requirements and recommendations of the drug licensing authorities are also taken into account.
• Continuous dialogue with manufacturers and users is an integral part of the process.
• Firming up of a monograph takes place only after comments on test methods and limits of acceptance
are agreed to by users subject to, in some cases, approval by licensing authorities
13

INDIAN PHARMACOPOEIA
14

CONTD.
• As per the Drugs and Cosmetics Act 1940, the Indian Pharmacopoeia legally
recognized book of Standards for the quality of drug substances and
preparations included therein.
• Published by the Indian Pharmacopoeia Commission which is an Autonomous
Institution under the Ministry of Health & Family Welfare, Govt. of India
• Sole authority for all prescription and over – the – counter medicines and other
health care products manufactured or sold in India
15

HISTORY
The pharmacopoeia originated as the Bengal Pharmacopoeia &
General Conspectus of Medicinal Plants, 1844 & was known as the
Bengal Pharmacopoeia.
The first pharmacopoeia was published in 1868 under the authority of
the Secretary of State for India.
 It contained standards for drugs official in the British
Pharmacopoeia (BP) 1867 & a few selected indigenous drugs.
16

CONTD.
The recognition of a pharmacopoeia as the official book of drug
standards came only with the process of passing legislation of the
Drugs and Cosmetics Act in 1940.
After independence an Indian Pharmacopoeia Committee, a
permanent body was constituted in 1948 and it prepared the
Pharmacopoeia of India (The Indian Pharmacopoeia) 1955.
17

CONTD.
DEVELOPMENT OF INDIAN PHARMACOPOEIA
EDITION YEAR OF
PUBLICATION
SUPPLEMENT CHAIRMAN
I 1955 1960 DR. R.N. Chopra
II 1966 1975 DR. B. Mukherji
III 1985 1981 DR. Nityanand
1991
IV 1996 2000 DR. Nityanand
2002
18

CONTD.
DEVELOPMENT OF INDIAN PHARMACOPOEIA
EDITION YEAR OF
PUBLICATION
SUPPLEMENT CHAIRMAN
V 2007 2008 DR. Nityanand
VI 2010 2012 DR. Ghulam
Nabi Azad
VII 2014 2015 DR. Ghulam
Nabi Azad
2016
VIII 2018 - DR. P.K.
Pradhan
19

MONOGRAPH FORMAT
TITLE
• Bold, Italics( PHYSICAL
CHARACTER)
• Chemical formula
CHEMICAL NAME
• According to IUPAC
CATEGORY
• Medicinal & Pharmaceutical
Basis
DESCRIPTION
STORAGE CONDITION
• Cold ( 2-8˚C )
• Cool( 8-25˚C)
• Warm(30-40˚C)
20

CONTD.
CONTAINERS
• SEPARATE APPENDIX
• HERMATICALLY SEALED
• SINGLE UNIT DOSE
CONTAINER
• MULTIPLE UNIT DOSE
CONTAINER
LABELLING OF DRUGS
STANDARD EXPRESSION
ASSAY PROCEDURE
REFERENCE SUBSTANCE AND
STANDARD PREPARATION
IDENTIFICATION TEST
21

AYURVEDIC PHARMACOPOEIA OF INDIA
22

CONTD.
• AYU (Life) + VEDA (Knowledge) = Ayurveda.
• Lord brahma created Ayurveda along with the creation of mankind &
universe.
• Ayurveda is holistic system of healing which evolved among brahmin sages
of ancient India some 3000-5000 years ago.
23

CONTD.
Ayurveda written in ancient India, contains padartha vigyan or the
knowledge of raw materials- so basic to medicinal preparations.
gives elaborate knowledge about bhaishajya kalpana (Bhaishajya
=medicine & kalpana=forms).
• API came to existence in 1962.
• Ayurveda pharmacopoeia committee(APC) was first functional unit at
department if AYUSH.
24

CONTD.
• In April 2006, it was shifted under Central Council for Research in Ayurveda
and Siddha (CCRAS).
• At present about 1,000 single drugs & 8,000 compound formulations are
used in the Ayurveda system including drugs of plants, animal and mineral
origin both single & compound formulations.
25

CONTD.
AYURVEDIC FORMULARY OF INDIA - PUBLICATIONS
API YEAR NUMBER OF PUBLICATIONS
PART I 1978 444
PART II 2000 191
PART III Draft stage(English &
Hindi)
-
26

AYURVEDIC PHARMACOPOEIA OF INDIA
PUBLICATIONS
AYURVEDIC PHARMACOPOEIA OF INDIA - PART I
VOLUME YEAR OF PUBLICATIONS NUMBER OF MONOGRAPHS
I 1990 80
II 1999 78
III 2001 100
IV 2004 68
V 2006 92
VI 2008 101
VII 2008 21(MINERALS & METALS)
27

CONTD.
AYURVEDIC PHARMACOPOEIA OF INDIA - PART II
VOLUME YEAR OF PUBLICATIONS NUMBER OF MONOGRAPHS
I 2007 50
II 2008 51
III 2010 51
28

API MONOGRAPH FORMAT
MONOGRAPH TITLE:
• SANSKRIT language is used.
INTRODUCTORY PARA:
• Biological source
• Geographical source
SYNONYM:
• Referenced in English and Urdu
DESCRIPTION:
• Organoleptic properties
• Microscopy
IDENTITY, PURITY & STRENGTH:
• Foreign organic matter
• Total ash
• Acid insoluble ash
• Extractive value are determined.
29

CONTD.
PHYSIOLOGICAL PROPERTIES:-
 THIN LAYER CHROMATOGRAPHY:
• Number of spots (RF value)
CONSTITUENTS: Name of const.
PROPERTIES & ACTION:
• Pharmacological principal
IMPORTANT FORMULATION &
THERAPEUTIC USES:
• Ayurvedic formulary
• Ayurvedic classic
DOSES:
• In metric system
FOR COMPOUND FORMULATIONS:
 Method of preparation
 Storage
 Physiological parameters
30

UNANI PHARMACOPOEIA
31

CONTD.
• The Unani system if medicine; sometimes referred to as Greco-Arab medicine or Unani
Tibb; is based on Greek philosophy.
• Aesculapius is credited as originator of this system.
• The human body is composed of 4 basic elements: EARTH, AIR, WATER, & FIRE having
cold, hot, wet & dry temperaments respectively.
• It constituted in 1965.
• It is a form of traditional medicine widely practiced in South Asia.
• It is based on the concept of 4 humors: Yellow bile, Black bile, Blood & Phlegm.
32

UNANI PUBLICATIONS
S. NO. PUBLICATION OF UNANI PHARMACOPOEIA NUMBER
OF DRUGS
1 Unani Pharmacopoeia of India Volume I 45
2 Unani Pharmacopoeia of India Volume II 50
3 Unani Pharmacopoeia of India Volume III 53
4 Unani Pharmacopoeia of India Volume IV 50
5 Unani Pharmacopoeia of India Volume V 52
33

MONOGRAPH FORMAT
MONOGRAPH TITLE:
• Bold, Unani Name.
INTRODUCTORY PARA:
• Geographical source
OTHER NAME:
• Include Name in Regional Language
DESCRIPTION:
• Microscopy
IDENTITY, PURITY & STRENGTH:
• Total ash
• Acid insoluble ash
34

CONTD.
THIN LAYER CHROMATOGRAPHY:
• Number of spots (RF value)
CHEMICAL CONSTITUENTS:
• Name of constituents
TEMPERAMENT:
• Nature of Drug(Hot, Cold)
ACTION:
• MUQAWWI-E-QALB(Cardio Tonic)
• MUQUAWWI-E-JIGAR(Liver Tonic)
THERAPEUTIC USE:
• Mentioned in Arabic & English
• E.g. ZOF-E-ALAM (General Weakness)
DOSE:
• Given in gm OR ml.
35

SIDDHA PHARMACOPOEIA
36

CONTD.
Sages who attained ‘Siddhi’ or Heavenly bliss and super natural powers by meditation
are named as Siddhas.
‘Siddha’ is a Sanskrit term, which means ‘perfection’
The known history of Siddha Vigyan began with the sage AGATHIYAR who is believed
to be the father figure of Tamil civilization and Tamil medicine.
The sages of South India, who practiced and established a Medical system to serve
the humanity. Those sages were called as Siddhars and the medical system pro-
founded by them is called as Siddha system of medicine.
37

CONTD.
• SPI established by Government of India under APC in 1964
under chairmanship of DR.C.S Uthamarayan.
• Siddha pharmacopoeia of India ,part I, volume I was printed in
June 2008.
• Available in 2 volumes volume I contains 73 single Drug
monographs & volume II is under progress.
38

FORMAT OF SPI MONOGRAPH
MONOGRAPH TITLE:
• Name of the drug given in
TAMIL
INTRODUCTION
• Botanical name & part used
with geographical source &
brief description about
cultivation & collection is also
mention
SYNONYM
• In other Indian regional
languages
DESCRIPTION
• Macroscopy & Microscopy
39

CONTD.
ASSAY
• TLC Analysis
• HPLC & HPTLC Analysis
CONSTITUENTS
• Important constituents are
mentioned
PROPERTIES & ACTION
• Mentioned in TAMIL
IMPORTANT FORMULATION
• Mentioned in SIDDHA
CLASSICS
THERAPEUTIC USE
DOSE
• Mentioned in Gm or ml
40

GERMAN HOMOEOPATHIC PHARMACOPOEIA
41

HISTORY
• The history of homeopathy begins with the discoveries of its
founder Samuel Hahnemann(1755-1843), a German physician.
• Hahnemann first coined the word "homeopathy" ("homoios" in
Greek means similar, "pathos" means suffering)
• The law of similar is the basis of homeopathic pharmacopoeia.
42

PUBLICATIONS
Serial Number VOLUME YEAR OF PUBLICATION
1. Volume I 1971 (Reprinted I 1989)
2. Volume II 1974(First edition)
1984(Second edition)
3. Volume III 1978
4. Volume IV 1985
5. Volume V 1986
6. Volume VI 1990
7. Volume VII 1999
8. Volume VIII 2007
43

FORMAT OF MONOGRAPH
MONOGRAPH TITLE
• Bold (LATIN)
BOTANICAL NAME
• Italics, Latin, Drug Family
COMMON NAME
• Hindi, English etc.
DESCRIPTION
• Description of leaf, flower
PART USED
• Mention part of Drug
44

CONTD.
MACROSCOPIC CHARACTER
• Colour, Odour etc.
MICROSCOPIC CHARACTER
• For powdered drug
IDENTIFICATION
• Identification tests
DISTRIBUTION
HISTORY & AUTHORITY
PREPARATION
• Include formulation
• Potency
45

UNITED STATES PHARMACOPOEIA
46

CONTD.
• USP is a pharmacopoeia published annually by united states
pharmacopoeial convention
• It contains standards for medicines, dosage forms, drug substances,
excipients, biologics, compounded preparations, medical devices,
dietary supplements, & therapeutics.
47

FORMAT OF MONOGRAPH
NAME
ADDED SUBSTANCE
DESCRIPTION
SOLUBILITY
IDENTIFICATION TESTS
ASSAY
IMPURITIES & FOREIGN
SUBSTANCES
PERFORMANCE TESTS
STORAGE CONDITIONS
48

JAPANESE PHARMACOPOEIA
49

CONTD.
• JP is published by the Japanese Government, The Ministry of
Health, Labor & Welfare (MHLW) Ministerial Notification.
• First published on June 25, 1886 & implemented on July 1,
1887.
• JP is published in accordance with the provisions of Article 41-1
of the Pharmaceutical Affairs Law (PAL) of Japan.
50

FORMAT OF MONOGRAPH
ENGLISH TITLE
 COMMONLY USED NAME
• LATIN TITLE
• TITLE IN JAPANESE
STRUCTURAL FORMULA
LIMIT OF CONTENT OF
INGREDIENT
LABELLING REQUIREMENT
METHOD OF PREPARATION
DESCRIPTION
IDETIFICATION, PURITY &
SPECIAL TESTS
ASSAY
CONTAINER & STORAGE
51

BRITISH PHARMACOPOEIA
52

CONTD.
• The BHP is a very useful aid to quality assurance, particularly for herbs
not featured in official pharmacopoeias.
• Prepared by British herbal medicine association in 1964.
• Two volumes of British herbal compendium volume I and volume II.
• 1983 edition contain 233 monographs on single herbal drugs and
BHP 1996 provide quality standards for 169 herbal raw materials.
53

FORMAT OF MONOGRAPH
MONOGRAPH TITLE
• Name of drug (BOLD)
• Family of drug
SYNONYM :-
• GIVEN IN ENGLISH
INTRODUCTION :-
CHARACTERSTIC :-
• Macroscopic Character
• Microscopic Character
IDENTIFICATION
• Identification tests
• TLC method
54

CONTD.
QUANTITATIVE STANDARD
• Total Ash & Acid soluble ash
MATERIAL OF COMMENCE
• Form in which drug is supplied
• Place of collection
POWDERED DRUG
• Characteristic of powder
ACTION
• Mode of action
STORAGE
• Statement is advisory
55

EUROPEAN PHARMACOPOEIA
56

CONTD.
• The European Pharmacopoeia (Ph. Eur.) listing a wide range of active
substances & excipients used to prepare pharmaceutical products
in Europe.
• Developed by the European Directorate for the Quality of
Medicines (EDQM) and is a part of the Council of Europe.
• It has a different legal basis from the others, being established as the
result of a treaty.
57

PUBLICATION
S.NO EDITION YEAR OF PUBLICATION
1. I EDITION 1967
2. II EDITION 1980
3. III EDITION 1997
4. IV EDITION 2001
5. V EDITION 2004
6. VI EDITION 2007
58

FORMAT OF MONOGRAPH
MONOGRAPH TITLE
• In ENGLISH, LATIN subtitle
DEFINITION
• Official definition
• Limit of content
CHARACTER
ASSAY
SOLUBILITY
• Measured at 15-25
TESTS
• Content of essential oil
• Content of active principle
• Total ash, sulphated ash & alcohol
soluble ash
STORAGE
59

COMPARATIVE STUDY
S.NO I.P A.P.I U.P S.P.I G.H.P USP J.P BHP E.P
TITLE BOLD
ENG.
SANSK. UNANI TAMIL LATIN ENG ENG. ENG. ENG.
SYN. ENG. SANSK. PER. &
ARAB.
TAMIL REG. ENG. ENG. ENG. ENG.
DESC. ++ ++ ++ ++ ++ ++ ++ ++ ++
ASSAY ++ __ __ ++ __ ++ ++ __ ++
ACTION ++ SANS ARAB TAMIL __ ++ __ ++ __
STORAGE ++ __ __ __ __ ++ ++ ++ ++
60++= present
__ = absent

CONTD.
S.NO I.P A.P.I U.P S.P.I G.H.P. USP J.P BHP E.P
DOSE ++ ++ ++ ++ __ ___ __ __ __
TEMP. __ __ ++ __ __ ___ __ __ __
I.TEST ++ ++ ++ ++ ++ ++ ++ ++ ++
MAT. OF
COM.
__ __ __ __ __ __ __ ++ __
MICROB.
CONT.
++ __ __ __ __ ++ ++ ++ __
HEAVY MET. ++ __ __ __ __ ++ ++ ++ __
61++= present
__ = absent

CONCLUSION
• The availability of various types of herbal monograph will
help fill the current need for information on quality control
and safe , responsible use of herbal products.
62

REFERENCE
• https://slideplayer.com/slide/4343734/
• http://ayush.gov.in/sites/default/files/Ayurve
dic%20Pharmacopoeia%20of%20India%2
0part%201%20volume%20IX.pdf
• www.sciencedirect.com
• C.K. Kokate; Pharmacognosy
• Indian pharmacopoeia
• Ayurvedic pharmacopoeia of India
• Homeopathic pharmacopoeia
• Unani pharmacopoeia
• Siddha pharmacopoeia of India
• Japanese pharmacopoeia
• European pharmacopoeia
• https://www.slideshare.net/gopinathkarnam
/ayurveda-pharmacopoeia
• https://www.slideshare.net/Shikhabhardwaj
25/monograph-ppt
63

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