Monograph ppt
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The document provides an overview of various pharmacopoeias, including the Indian Pharmacopoeia, Ayurvedic Pharmacopoeia, Unani Pharmacopoeia, Siddha Pharmacopoeia, British Herbal Pharmacopoeia, Japanese Pharmacopoeia, and United States Pharmacopoeia. Each pharmacopoeia outlines the standards for drug substances and preparations, including monograph formats that cover aspects like chemical names, descriptions, tests, and therapeutic uses. It emphasizes the importance of these texts for ensuring the quality and efficacy of medicinal products.
Monograph ppt
- 1. Presented By: Shikha Bhardwaj M.Pharmacy 1st Semester (Pharmacognosy)
- 2. WHAT IS A PHARMACOPOEIA ? o Pharmacopoeia: the word derives from the ancient Greek word pharmakon-drug & poeia- to make. o 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. The pharmacopoeia contain:- List of drug and other related substances Sources Description Tests Formulas for preparation Uses Doses Storage conditions
- 4. o Definition: a detailed written study of a single specialized subject or an aspect of it . or o A monograph is a book ,pamphlet or document that is complete in itself . • Researchers publish their findings in monographs so their peers can review and validate their findings. MONOGRAPH
- 5. Provide a reliable basis for judging the quality of the drug substances Way to control Adulterated and contaminated medicines Set standards for the quality , purity , strength Concise description of a single substances Reference for pharmaceutical drug specifications
- 7. 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.
- 8. 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 V 2007 2008 Dr. NITYANAND V1 2010 2012 Dr. Ghulam Nabi Azad V11 2014 2015 Dr. Ghulam Nabi Azad 2016 V111 2018 _ Dr. P. K. Pradhan
- 9. Monograph Developed 0 500 1000 1500 2000 2500 3000 3500 1985 1996 2007 2010 2014 2018 Column1 Column1
- 10. MONOGRAPH FORMAT • Name: Drug name ,Chemical Formula • Chemical Name: According to IUPAC • Category: Medicinal & Pharmaceutical Aid • Description: Macroscopic & Microscopic features • Solubility: Aqueous or organic solvents
- 11. o Standards –, TLC identification. For TLC, reference solution is a certified sample of genuine drug supplied by IPC. o TESTS – a)foreign organic matter b)Ethanol soluble extractive c)Water soluble extractive d)Ash value e)Acid insoluble ash
- 12. e) Heavy metals f) Loss on drying g) Microbial contamination o Assay o Labeling of drugs o Specific storage conditions.
- 14. Ayurveda is a holistic system of healing which evolved among Brahmin sages of ancient India some 3000-5000 years ago. It focuses on establishing & maintaining balance of the life energies within us rather than focusing on individual. API came into existence in 1962. At present about 1,000 single drugs and 8,000 compound formulations are used in the Ayurveda system including drugs of plants, animal and mineral origin both single and compound formulations.
- 15. Publication of Ayurvedic Pharmacopeia year No. of drugs 1.) Ayurvedic Pharmacopoeia of India Vol. I 1986 80 2.) Ayurvedic Pharmacopoeia of India Vol. II 1999 78 3.) Ayurvedic Pharmacopoeia of India Vol. III 2001 100 4.) Ayurvedic Pharmacopoeia of India Vol. IV 2004 68 5. ) Ayurvedic Pharmacopoeia of India Vol. V 2006 92 6.) Ayurvedic Pharmacopoeia of India Vol. VI 2008 101 7. Ayurvedic Pharmacopoeia of India Vol. VII ( Minerals and Metals) 2008 21 8.)Ayurvedic Pharmacopoeia of India Vol.V111 2010 60
- 16. o MONOGRAPH TITLE :- name given on the top of each monograph is given in Sanskrit. o INTRODUCTORY PARA :- Botanical name along with part used . Geographical source. o SYNONYM :- Mentioned in English & Urdu.
- 17. o DESCRIPTION :- Macroscopy Microscopy Powder characteristic o IDENTITY, PURITY AND STRENGTH – Foreign matter Total ash Acid insoluble ash & Extractive value are determined. o Physico-chemical Parameters o T.L.C :- Number of spot (Rf VALUE) determine identity. o CONSTITUENTS :- o PROPERTIES AND ACTION:- Pharmacological principle
- 18. o IMPORTANT FORMULATION AND THERAPUTIC USES:- Ayurvedic formulary Ayurvedic classic o DOSES:- In metric system Method of preparation Storage Physiochemical parameters
- 20. It is a form of traditional medicine widely practiced in south Asia. Unani medicine is based on the concept of 4 humors-phlegm, blood, yellow bile & black bile UPI constituted in 1965.
- 21. S.NO PUBLICATION OF UNANI PHARMACOPOEIA NO.OF DRUGS 1.) Unani Pharmacopoeia of of India Vol I 45 2.) Unani Pharmacopoeia of India Vol II 50 3.) Unani pharmacopoeia of India Vol III 53 4.) Unani pharmacopoeia of India Vol IV 50 5.) Unani pharmacopoeia of India Vol V 52 Development of Publication
- 22. FORMAT OF MONOGRAPH o MONOGRAPH TITLE :- The name given on the top of each monograph is in unani. Unani name along with the part used in the bracket underneath it. o INTRODUCTORY PARA :- Botanical name and geographical location. o OTHER NAME :- Include name in regional language o DESCRIPTION :- Macroscopy Microscopy Powder characteristics.
- 23. o IDENTITY, PURITY AND STRENGTH :- Foreign matter Total ash Acid insoluble ash o T.L.C :- Number of spots ( Rf values ) are determined o CHEMICAL CONSTITUENTS :- Name of the constituents are mentioned. o TEMPERAMENT like hot, moist, cold, dry etc. are mentioned. o ACTION :- MUQAWWI-E-QALB (CARDIAC TONIC) MUQUAWWI-E-JIGAR (LIVER TONIC )
- 24. o THERAPEUTIC USE :- MENTIONED IN ARABIC AND ENGLISH Example :- ZOF-E-ALAM (GENERAL WEAKNESS) o DOSE :- Given in gm OR ml
- 26. o This system of medicine was developed by sages of south India to serve humanity. o SPI established by Government of India under APC in 1964 under chairmanship of Dr.C.S Uthamarayan. o Siddha pharmacopoeia of india ,part I, vol I was printed in June 2008.. o Available in 2 volumes volume I contains 73 single drug monographs & volume II is under progress.
- 27. FORMAT OF S.PI MONOGRAPH MONOGRAPH TITLE:- The name given on the top of each monograph is in Tamil. INTRODUCTION :- Botanical name & part used with geographical source & brief description about cultivation & collection is also mentioned. SYNONYM :- Synonyms in other Indian regional languages. DESCRIPTION :- macroscopy microscopy powder microscopy.
- 28. ASSAY :- TLC ANALYSIS HPLC& HPTLC ANALYSIS. CONSTITUENTS :- Important constituents are mentioned PROPERTIES AND ACTION :- Mentioned in Tamil IMPORTANT FORMULATION :- MENTIONED IN SIDDHA CLASSICS THERAPEUTIC USE :- DOSE :- MENTIONED IN gm OR ml
- 30. • 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 vol 1 & vol 2. • 1983 edition contain 233 monograph on single herbal drug and BPH 1996 provided quality standard for 169 herbal raw materials.
- 31. Format for monograph Title: name of drug family of drug Synonym: given in English Introduction: Biological source of drug Characteristic: macroscopic microscopic
- 32. Identification: Identification tests TLc Method Quantative standard: foreign matter total ash acid soluble ash Material of commence: form in which drug is supplied place of collection
- 33. Powdered Drug: characteristic of powder Action: mode of action Storage
- 35. JP is published by the Japanese government, the ministry of health, labour and welfare ministerial notification. First published on June 25,1886 and implemented on July 1,1887. JP is published in accordance with the provisions of article 41-1 of the Pharmaceutical affairs law (PAL) Japan.
- 36. Format of monograph English title Commonalty used name Latin title Title in Japanese Structural formula Limit of content of ingredient Labelling requirement Method of preparation
- 37. Description Identification tests Purity test Special test Assay Container and storage
- 39. USP is a pharmacopoeia for the united states published annually by united states pharmacopoeial convention. It contains standards for medicines, dosage forms, drugs substances, excipients, biologics, compounded preparations, medical devices, dietary supplements, and therapeutics.
- 40. Format of monograph Name Added substance Description Solubility Identification tests Assay Impurities and foreign substances Performance tests Storage conditions
- 41. COMPARATIVE STUDY S.NO I.P A.P.I U.P S.P.I BHP J.P USP TITLE BOLD ENG. SANSKRIT UNANI TAMIL ENG. ENG. ENG. SYN. ENG. SANSKRIT PER.&ARA B TAMIL ENG. ENG. ENG. DESC. + + + + + + + ASSAY + _ _ + _ + + ACTION + SANS ARAB TAMIL + _ + STORAGE + _ _ _ + + + DOSE + + + + _ _ _ TEMP. _ _ + _ _ _ _ I.TEST + + + + + + + MICROB. CONT. + _ _ _ + + + HEAVY METAL + _ _ _ + + +
- 42. 1. Indian Pharmacopoeia 2. Ayurvedic Pharmacopoeia 3. Siddha Pharmacopoeia 4. Unani Pharmacopoeia 5. United state Pharmacopoeia 6. Japanese Pharmacopoeia 7. www.ipc.nic.in 8. www.wikipedia.com