Quality and quality control of herbal drugs, extracts and phytomedicines

Abstract

This article deals with quality criteria of the herbal drugs (starting material), extracts and phytomedicines (finished products). Besides, the main aspects of control procedure are given (identity, purity and content of active or marker constituents). Identity of herbal drug can be verified by macroscopical and microscopical examinations. Additionally, chemical reactions and TLC-fingerprints are used to confirm the identity. Purity of the samples can be control trough the determination of foreign matter, total ash, acid insoluble ash, sulfated matter, loss of drying... The present of pesticides, fumigation agents, heavy metals, radioactive contamination, mycotoxines as well as microbiological quality must be determinated. The determination of residual solvents are important for extracts. For the examination of active constituents of herbal drugs, extracts of phytomedicines mostly spectrophotometric or chromatographic methods are applied.

U svetu je na različit način regulisan status biljnih droga i fito-preparata, a samim tim i njihova distribucija i primena. U većini zemalja Evropske Unije, prema Direktivama 65/65 EEC, 75/318 ECC, 75/319 ECC i svim kasnijim pratećim aktima, fitopreparati su prihvaćeni kao lekovi (najčešće, kao lekovi koji mogu biti izdavani bez lekarskog recepta Over the Counter lekovi - OTC). Njihova registracije je zasnovana na potvrđenom kvalitetu, ne škodljivosti i efikasnosti. U Holandiji, Velikoj Britaniji i naročito u Sjedinjenim Američkim Državama samo mali broj biljnih droga je registrovan kao OTC preparati. Na osnovu donošenja The Dietary Supplement Health and Education Act of 1994 (DSHEA) i formiranja Commision on Dietary Supplement Labels (CDSL) 1995. god., najveći broj ovih preparata se na tržištu distribuira kao Diethary supplement. Bez obzira na različit status u SAD, Nemačkoj i Velikoj Britaniji (kao najznačajnijim primerima) uvek postoje zahtevi da ovi preparati moraju zadovoljiti osnovne zahteve kvaliteta i neškodljivosti (1,2,3,4).