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Title: Comparative review of the requirements of the european pharmacopoeia 6.0 and the pharmacopea yugoslavica 2000 for herbal drugs and herbal drug preparations
Authors: Pavlović D.
Vuleta G.
Kovačević N.
Issue Date: 1-Dec-2010
Journal: Arhiv za Farmaciju
Abstract: Herbal medicinal products and traditional herbal medicinal products consist of one or more herbal drugs (substances) and/or herbal drug preparations (herbal preparations). The main request for the quality of herbal drugs and herbal drug preparations are given in the pharmacopoeias. This paper deals with comparative analyses of the monographs for the active constituents of herbal products/traditional herbal products which are presented in the European Pharmacopoeia sixth edition (Ph.Eur.6.0) and Yugoslav pharmacopoeia 2000. (Ph.Jug.V). Ph.Eur.6.0 contains general monographs for Herbal drugs, Herbal drug preparations and Extracts (Tinctures, Liquid extracts, Dry extracts and Soft extracts). Further, Ph.Eur.6.0 contains monographs about Herbal teas. Ph.Jug.V contains only general monographs for Extracts and Tinctures. Both pharmacopoeias, in the first part and through the general monographs define some methods and procedures for the herbal drugs/herbal drugs preparations testing and assessment. The values of different parameters are given in the general monographs of herbal drugs/herbal drugs preparations or in the individual monographs. In both documents, without some important differences, procedures for some test and parameters are given in the part 2. Methods of analyses within chapters 2.1. Apparatus, 2.2. Physical and physicochemical methods, 2.4. Limit tests, 2.5. Assays, 2.6. Biological test and 2.8. Methods in pharmacognosy. Regarding health safety, in addition to microbiological safety, Ph.Eur.6.0 as well as Ph.Jug.V requires testing on heavy metals, pesticides and radioactivity. Further, Ph.Eur.6.0 requests confirmation that starting material is free from myco-toxins (aflatoxin) and viruses (for animal drugs). The presence of general monographs for Herbal drugs, Herbal drug preparations, Extracts and Herbal teas in the Ph.Eur.6.0 enable quality control during the process of production of herbal medicinal products/traditional herbal medicinal products: control of row material, interphase control and control of final products. General monographs in the Ph.Eur.6.0 can bee apply for the control of the un-officinal herbal drugs. This is very important for improvement of the production process and quality of products, as well as for the inspection of herbal medicinal products/traditional herbal medicinal products taken from the market.
ISSN: 00041963
Appears in Collections:Naučne i umetničke publikacije

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