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Biljni lekovi - zahtevi za kontrolu kvaliteta i dobra proizvođačka praksa
Herbal remedies: Quality control requirements and good manufacturing practice
Institut za proučavanje lekovitog bilja 'Dr Josif Pančić', Beograd, Srbija
Sažetak
Narodno lečenje biljem može biti raznovrsno i značajno, naročito u slabo razvijenim zemljama, gde je tradicionalna ili narodna medicina sastavni deo zvaničnog sistema zdravstvene zaštite, dok je u razvijenim zemljama Evrope i sveta, razvijen koncept racionalne fitoterapije. Iako se biljni lekovi koriste vekovima unazad, standardi i zahtevi za kontrolu istih, iz godine u godinu su sve strožiji i veći. Važno je razumeti problematiku kontrole i proizvodnje ove vrste lekova, počev od specifičnosti polaznih sirovina do završnog proizvoda. U ovom radu dati su propisi uvedeni u kontrolu i proizvodnju biljnih lekova, u cilju njihovog unapređenja i razvoja. Važno je naglasiti da isti pristup proizvodnji i kontroli kvaliteta treba primeniti na biljne lekove, kao i na tradicionalne biljne lekove. Cilj rada je i da se naglasi značaj biljnih lekova u svetu i kod nas, s obzirom da oni i dalje predstavljaju neiscrpan izvor za nova naučna saznanja. Njihov značaj za farmakološka istraživanja i razvoj leka nije samo zbog aktivnih biljnih sastojaka, koji se kao takvi koriste u terapijske svrhe, već i što oni predstavljaju polazni materijal za sintezu lekova, ili kao modeli za dobijanje novih, farmakološki aktivnih supstanci.
Abstract
The use of medicinal plants is significant, especially in developing countries where traditional medicine is an integral part of the formal health care system, while in the developed countries in Europe and all over the World, developed the concept of a rational phytotherapy. Although herbal medicines are in use for centuries, standards and requirements of their control, from year to year are becoming stricter and on higher level. It is important to understand the issues of control and production of this type of drugs, ranging from specific raw materials to finished products. In this paper we report how have introduced regulations to control production of herbal medicines in order to induce improvement and development. It is important to note that the same approach to production and quality control should be applied to herbal medicines and traditional herbal remedies. The aim of this text is to emphasize the importance of herbal medicines in the world and in our country since they still represent an inexhaustible source of new scientific knowledge. Their importance for pharmacological research and drug development not only for the active herbal ingredients which are used as they are for therapeutic purposes, but also because they represent a starting material for the synthesis of drugs or as models for the production of new, pharmacologically active substances.
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