The document provides an overview of the Ayurvedic Pharmacopoeia of India (API), Ayurvedic Formulary of India (AFI), and other international pharmacopoeias. It discusses that API and AFI were established to standardize Ayurvedic drugs and formulations and enforce the Drugs and Cosmetics Act. API contains monographs for single drugs specifying identification, purity, and strength standards. AFI contains over 1500 compound Ayurvedic formulations along with details of constituent ingredients. The document also gives a brief introduction to pharmacopoeias in general and describes some other prominent international pharmacopoeias.
Nighantus of Ayurveda help in the right identification of the plant species used in treatment. It is essential to understand the basics of the evolution of Dravyaguna right from the Vedic period to the current era for a Materia Medica scholar in the field of Ayurveda.
Anukta dravya- Unexplored or Undocumented Medicinal PlantsAditi Gandhi
Determination of Anukta Dravya or Undocumented medicinal plants in ayurveda and criteria of nomenclature and how to expand the Ayurvedic Pharmacopoeia of India.
Nighantus of Ayurveda help in the right identification of the plant species used in treatment. It is essential to understand the basics of the evolution of Dravyaguna right from the Vedic period to the current era for a Materia Medica scholar in the field of Ayurveda.
Anukta dravya- Unexplored or Undocumented Medicinal PlantsAditi Gandhi
Determination of Anukta Dravya or Undocumented medicinal plants in ayurveda and criteria of nomenclature and how to expand the Ayurvedic Pharmacopoeia of India.
METHODOLOGY OF STUDYING CONTROVERSIAL DRUGS-1.pptxhelipatel85
Controversy is very important subject to study for ayurvedic drug .Many drugs we are using for medicinal puprpose have controversy so here i tried to explain basic method to resolve controversy and every physician should follow it .
Aushada is one which can be taken in disease, in alpha matra, even in severe condition, many doshas involved. Taken in specific disease, aushada which is of good quality, in proper dose should destroy it, without any complications.
'Rasasastra' ,is the science of metals , minerals , other toxic herbs , which are applied for attaining two goals. It is either used in the perspective of metallurgy, where lower metals are converted in to higher metals. It is otherwise used for the attainment of supreme health. This science , with both the applications were once well practiced in our country. But due to several factors, this divine science has been restricted to treatment aspect. 'Kshetreekarana' is the method of preparing the body to be eligible for administering processed divine mercury. In the midst various references Kshetreekarana generally , includes two steps. The first step is implementing Panchakarma therapy and second step involves administration of special formulations to attain a healthy condition to accept the divine mercury.
'Bandha' literally means bonding. In Rasasastra , the science of metals and minerals , a special phenomenon , known as Bandha is explained in the context of Parada( Mercury). Mercury is considered as the supreme drug , which can cure any disease. But the inclusion of mercury in a required medicine is a tedious task, because of its instability as a solid form, its heat intolerance etc. To convert mercury into a suitable dosage form , it is necessary to stabilize the same with other suitable drugs ( Herbs/ Metals/ Minerals etc) with or without the aid of heat. Thus stabilized Mercury can assure a tremendous therapeutic effect and offer better health.
METHODOLOGY OF STUDYING CONTROVERSIAL DRUGS-1.pptxhelipatel85
Controversy is very important subject to study for ayurvedic drug .Many drugs we are using for medicinal puprpose have controversy so here i tried to explain basic method to resolve controversy and every physician should follow it .
Aushada is one which can be taken in disease, in alpha matra, even in severe condition, many doshas involved. Taken in specific disease, aushada which is of good quality, in proper dose should destroy it, without any complications.
'Rasasastra' ,is the science of metals , minerals , other toxic herbs , which are applied for attaining two goals. It is either used in the perspective of metallurgy, where lower metals are converted in to higher metals. It is otherwise used for the attainment of supreme health. This science , with both the applications were once well practiced in our country. But due to several factors, this divine science has been restricted to treatment aspect. 'Kshetreekarana' is the method of preparing the body to be eligible for administering processed divine mercury. In the midst various references Kshetreekarana generally , includes two steps. The first step is implementing Panchakarma therapy and second step involves administration of special formulations to attain a healthy condition to accept the divine mercury.
'Bandha' literally means bonding. In Rasasastra , the science of metals and minerals , a special phenomenon , known as Bandha is explained in the context of Parada( Mercury). Mercury is considered as the supreme drug , which can cure any disease. But the inclusion of mercury in a required medicine is a tedious task, because of its instability as a solid form, its heat intolerance etc. To convert mercury into a suitable dosage form , it is necessary to stabilize the same with other suitable drugs ( Herbs/ Metals/ Minerals etc) with or without the aid of heat. Thus stabilized Mercury can assure a tremendous therapeutic effect and offer better health.
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
format of monograph
AYURVEDIC PHARMACOPOEIA
format of monograph
UNNANI PHARMACOPOEIA
format of monograph
SIDDHA PHARMACOPOEIA
format of monograph
GERMAN HOMOEPATHIC PHARMACOPOEIA
format of monograph
US PHARMACOPOEIA
format of monograph
JAPANESE PHARMACOPOEIA
format of monograph
BRITISH PHARMACOPOEIA
format of monograph
EUROPEAN PHARMACOPOEIA
format of monograph
COMPARATIVE STUDY
CONCLUSION
Reference
Description about what is pharmacopoeia? different pharmacopoeia and there edition. What is monograph and there comparative studies in different pharmacopoeias along with monograph format in per different pharmacopoies.
In this slide contains Monographs of Herbal Drugs Study in British Herbal Pharmacopoeia and American Herbal Pharmacopoeia.
Presented by: M.SUDHEESHNA (Department of pharmaceutical analysis ).RIPER, anantapur
Introduction to Pharmacy & Pharmaceutics.pptxRAHUL PAL
Pharmaceutics is the overall process of developing a new chemical entity into an approved therapy that is safe and effective in treating or preventing disease. It is a complex process requiring multiple scientific, medical, legal, commercial, and regulatory expertise.Pharmaceutics is the branch of pharmacy which deals with the formulation, manufacturing, evaluation, packaging of pharmaceutical dosage forms
The word pharmacy is derived from the Greek word “Pharmakon”, meaning medicine or drug. In other term, “Pharmacy may defined as the art and science of preparing (manufacturing) and dispensing of drugs prepared by the natural and synthetic sources and using for the treatment as well as prevention of diseases”. In general sense, it is the place where medicine or drugs are sold. Pharmacy is a health profession that links health science with chemical science and aims to ensure the safe and effective use of pharmaceutical drugs. It includes the collection, identification, synthesis, purification, isolation and quality control of medical substance or pharmaceutical products.
CHRONOLOGICAL DEVELOPMENT OF RASASHASTRA AND BHAISHAJYA KALPANADR AJITH KUMAR
This is a small assignment work given to the 2nd year UG BAMS students to know the basic chronological development of Rasashastra and bhaishajya kalpana
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DR. AJITH KUMAR AFTER PRESENTING THIS ARTICLE LIKE TO CONCLUDE THAT
PROCESSED MERCURY AND RAW MERCURY ARE COMPLETELY DIFFERENT. DONOT COMPARE YOUR RAW MERCURY WITH OUR ANCIENT PURIFIED MERCURY. HOW MUCH EVIDANCE YOU HAVE REGARDING MERCURY THE SAME WE HAVE IN CLASSICS . ACHARYAS ARE VERY MUCH BRILLIANT IN PREPARING MEDICINES BY SEEING ALL THESE TOXICITY AND ALL THEY HAVE TOLD ABOUT PURIFICATION TECHNIQUES IN DIFFERENT WAY.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
Synthetic Fiber Construction in lab .pptxPavel ( NSTU)
Synthetic fiber production is a fascinating and complex field that blends chemistry, engineering, and environmental science. By understanding these aspects, students can gain a comprehensive view of synthetic fiber production, its impact on society and the environment, and the potential for future innovations. Synthetic fibers play a crucial role in modern society, impacting various aspects of daily life, industry, and the environment. ynthetic fibers are integral to modern life, offering a range of benefits from cost-effectiveness and versatility to innovative applications and performance characteristics. While they pose environmental challenges, ongoing research and development aim to create more sustainable and eco-friendly alternatives. Understanding the importance of synthetic fibers helps in appreciating their role in the economy, industry, and daily life, while also emphasizing the need for sustainable practices and innovation.
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API, AFI – AN OVERVIEW BY DR AJITH KUMAR
1. AN OVERVIEW OFAPI, AFI, AND
OTHER INTERNATIONAL
PHARMACOPOEIAS
By – Dr Ajith kumar
Final Year P.G Scholar
Dept. of Rasashastra and Bhaishajya kalpana
Under the guidance of : Dr P.G Jadar M.D Ayu PhD
Professor and Dean
Dept of PG Studies in Rasashastra and bhaishajya kalpana
2. Topics covered
Introduction
Need for pharmacopoeia in Ayurveda
The APC
General introduction to pharmacopoeia
A brief overview of API
Formulary and AFI
Other International pharmacopoeias
Summary
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 2
3. Introduction
Drug and Cosmetic Act 1940 – regulation of import, manufacture,
and distribution of drugs in India
Primary objective of the act – ensure safety, efficacy, and quality
standards of drugs and cosmetics sold in India.
Amended in 1964 to include Ayurvedic and Unani drugs
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 3
4. Need for a pharmacopoeia in Ayurveda?
Controversy and confusion in identification of drugs.
Widespread geography of the country – multiple botanical sources of a drug.
Commercial substitution.
Foreign invasions, discouragement and negative attitude towards the system – Ayurvedic drugs
were wrongly published as crude, poisonous, and potentially dangerous.
Government had no control over manufacturing and marketing. Hence no control over quality
of these products.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 4
5. The Ayurvedic Pharmacopoeia Committee (APC)
Constituted by Govt of India on 20th September 1962
First functional unit of ministry of AYUSH
Purpose – to establish safety and toxicity profiles and standardize drugs and
formulations mentioned in our classics.
From 2006 it’s under CCRAS
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 5
6. As a result…
Unavailable laboratory data to feed monographs – PLIM ( Pharmacopoeia Laboratory of Indian
Medicine) was established in 1970 in Ghaziabad.
3 publications : AFI, API, and Atlas of Ayurvedic Pharmacopoeia drugs
AFI was published first in 1978, under Col. R N Chopra Committee which would provide
sufficient basis to enforce Drug and Cosmetic Act and also would be precursor to publish API
API was then published in 1986
ATLAS – 2009 (TLC) and 2011 (microscopy and macroscopy)
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 6
7. Pharmacopoeia
Derived from Greek, the word meaning is “drug-making”
What? – A legally binding collection for medicines used in a region
Who? – Prepared by national or regional authority
Why? – To state standards and quality specifications for medicines
Hence it can be defined as “It is a legally binding collection, prepared by a
national or regional authority of standards and quality specifications for
medicines used in that country or region.”
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 7
8. Role of pharmacopoeia
The role of a pharmacopoeia is to furnish quality specifications for active
pharmaceutical ingredients (APIs), finished pharmaceutical products (FPPs), and
general requirements, e.g. for dosage forms.
Quality specification :
It includes a set of tests that will help determine :
1. Quality and purity of a product
2. Ascertain the strength and amount of active ingredients in a product
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 8
9. API – THE AYURVEDIC PHARMACOPOEIA OF INDIA
- The API is a legal document of standards for the quality of
ayurvedic drugs
- It provides us some uniformity in the ayurvedic medicines
marketed, so far as their identity, purity and strength are
concerned.
- It is the book of reference for implementation of the drugs
and cosmetics act (1940).
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 9
10. Division of content
• API – PART 1
• Total 9 volumes
• 645 monographs on single drugs
• Vol.7 deals with metal and mineral origin
drugs
2/2/2023 10
volume Year of publication No of monographs
I 1990 80
II 1999 78
III 2001 100
IV 2004 68
V 2006 92
VI 2008 101
VII 2008 21(metals and
minerals)
VIII 2011 60 (aqueous and
hydroalcoholic
extracts)
IX 2016 45
11. •API part II
•3 volumes have been published
101 monographs.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 11
volume Year of publication No of monographs
I 2007 50 (formulations)
II 2008 51
III 2010 51
12. TLC Atlas of Ayurvedic Pharmacopoeial Drugs – Part 1, Vol. 1 – 2009 – 80
monographs
Microscopy and Macroscopy Atlas of API Drugs – Part 1, Vol. 1 – 2011 – 80
monographs
Microscopy and Macroscopy Atlas of API Drugs – Part 1, Vol. 5 – 2009 – 92
monographs
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 12
13. Contents of API
Preface
Introduction
Legal notices
General notices - for guidance of the analysts, the pharmaceutical suppliers, manufacturers
and the research workers engaged in this field.
Monographs
Appendices- details about the apparatus, reagents and solutions, tests, methods of preparations
of specimen for microscopic examinations have been given.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 13
14. MONOGRAPHS
• Title
• Definition - giving its identification in scientific nomenclature and very brief information
about its source, occurrence, distribution and precautions in collection if any etc, are mentioned
• Synonyms- in Sanskrit and also other Indian regional languages
• Description : Macroscopic – morphological characteristics and
Microscopic- its microscopic structure, the individual elements,
deposition of crystals etc. each having a pharmacognostic value in
identification.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 14
15. • Identity, purity and strength – gives norms and limits like tolerance of
foreign matter alcohol soluble extract
total ash water soluble extract
acid insoluble ash moisture content
• Constituents
• Properties and action- rasa panchakas
• Important formulations
• Therapeutic uses
• Dose
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 15
16. Formulary
It is a list of prescription drugs/medicines.
Contains collection of formulas for the compounding and testing of
medication.
Depending on individual formularies, some may also contain additional
clinical information such as side effects, contraindications, and doses.
156 countries – national or provincial essential medicine lists
135 countries – national treatment guidelines/formulary manuals
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 16
17. AFI – THE AYURVEDIC FORMULARY OF INDIA
Huge number of formulations scattered all over was
compiled.
List of single drugs of animal, mineral, and plant origin was
prepared on basis of names appearing in formulations, along
with official names and English equivalents.
Plant origin drugs have been edited according to botanical
names of plants appearing in formulations for convenience of
users.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 17
18. Other features
Ayurvedic terms of therapeutic indications and their appropriate English
equivalent has been mentioned.
The original shloka of reference from where the shloka has been derived has also
been included
Keeping in mind the non-availability of roots and barks and regulating laws of
the country, alternative parts of the plants have been indicated for the
formulations
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 18
22. Contents of AFI
Foreword
- Legal notice
- General notices
- Transliteration symbols
- Abbreviations for parts of plants
- Preface
- Introduction
- Formulary—compound formulations:
- Formulary—single drugs:
1. List of single drugs of animal origin.
2. List of single drugs of mineral origin.
3. List of single drugs of plant origin:
- Appendices:
2/2/2023 22
23. Formulary – compound formulations
Name of formulation in samskrit
Reference
Shloka
Name of drugs mentioned in shloka along with their : basonym (if synonym is given in shloka),
part used, quantity
Dose
Important therapeutic uses
Special method of preparation is mentioned only for some formulations
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 23
30. Appendicies
Appendices:
1. Paribhasa (Glossary of technical terms).
2. Sodhana (Process of detoxication).
3. Therapeutic indices:
(a). Formula wise.
(b). Disease wise.
4. List of diseases/technical terms and their approximate English
equivalents.
5. Metric equivalents of classical weights and measures.
6. Bibliography.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 30
35. Dosage forms and doses mentioned in AFI
Sl. No Dosage form General dose
1 Asava and Arista 12 to 24 ml
2 Arka 12 to 24 ml
3 Avaleha and Paka 6 to 12 gm
4 Kwatha churna 48 gm
5 Guggulu 3 gm
6 Ghrita 12 gm
7 Churna 1 to 6 gm
8 Taila 6 to 12 gm
for internal use
9 Dravaka 5 drops
10 Lavana kshara 1 to 2 gm
125 – 250 mg
2/2/2023 35
Sl.
No
Dosage form General dose
11 Lepa --
12 Vati and gutika 125 mg to 2 gm
13 Varti, Netrbindu, Anjana --
14 Sattva 1 gm
15 Kupipakva rasayana 62.5 to 125 mg
16 Parpati 125 to 250 mg
17 Pishti 62 to 125 mg (few
upto 500mg)
18 Bhasma upto 250 mg
19 Mandura 1 gm
20 Rasa yoga 125- 250 mg
21 Lauha 250 mg to 2 gm
36. Dose- general guidelines
Doses : Doses mentioned in the Formulary are intended merely for general
guidance
Represent, unless otherwise stated, the average range of quantities per dose which
are generally regarded as suitable for adults when administered orally.
It is not to be regarded as binding upon the prescribers.
It is to be noted that the relation between the doses in metric and Ayurvedic
Systems set forth in the text is of only approximate equivalence, and are for the
convenience of the prescriber and are sufficiently accurate for pharmaceutical or
other purposes.
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 36
43. 2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 43
Topics
44. To summarize…
Pharmacopoeias and formularies - Guidelines for approved
pharmaceutical standards – necessary for manufacture and
prescription of these formulations
Ensure quality control methods
An important component of the drug safety system
An instrument for patient and consumer protection
2/2/2023 AN OVERVIEW OF API, AFI, AND OTHER INTERNATIONAL PHARMACOPOEIAS 44