Stability testing of herbal medicines

Abstract

Nowdays, the use of products based on medicinal herbs (phytopreparates) are in scientific focus, both in prevention or in treatment of various diseases. Herbal products have been recognized as an excellent source of bioactive compounds which have positive effects on human health. Beside teas, as standard herbal products, phytopreparations are much more represented as final pharmaceutical form on the market today. Phytopreparations must satisfy standard quality, which means that they must be physically, chemically and microbiological stable and have a high degree of purity. In order to determine the stability, storage conditions, shelf-life of the products, stability tests are conducted, which involving tests of environmental factors influence: temperature, relative humidity, light. Stability tests are performed at different stages of development and production. In accordance with the EMEA (European Agency for Drugs and Medical Devices) for a variety of herbal preparations different specific stability tests are conducted.

Danas, sve je veći akcenat na upotrebi preparata na bazi lekovitog bilja (fitopreparata), kako u prevenciji tako i u lečenju različitih oboljenja. Biljni preparati su prepoznati kao odličan izvor bioaktivnih komponenti, koji imaju pozitivne efekte na zdravlje ljudi. Pored čajeva, kao standardnih biljnih proizvoda, danas su na tržištu mnogo više zastupljeni fitopreparati kao finalne farmaceutske forme. Fitopreparati moraju biti standardnog kvaliteta, što podrazumeva da moraju biti fizički, hemijski i mikrobilološki stabilni, da su standardizovanog sastava i da su visokog stepena čistoće. U cilju utvrđivanja koliko je jedan proizvod stabilan, definisanja uslova čuvanja, određivanja roka trajanja, sprovode se ispitivanja stabilnosti, koja podrazumevaju ispitivanja uticaja faktora okoline: temperature, relativne vlažnosti vazduha, svetlosti na promenu kvaliteta gotovog proizvoda. Ispitivanja stabilnosti se izvode u različitim fazama razvoja i proizvodnje. U skladu sa zahtevima EMEA (Evropska agencija za lekove i medicinska sredstva) za različite biljne preparate postavljaju se različiti specifični testovi stabilnosti.