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Pregledni rad – Review Paper

STABILITY TESTING OF HERBAL MEDICINES

By
Nada Ćujić ,
Nada Ćujić

Institute for Medicinal Plant Reasearch „Dr Josif Pančić“ , Belgrade , Serbia

Svetlana Ibrić ,
Svetlana Ibrić

Department for pharmaceutical technology, Faculty of Pharmacy, University of Belgrade , Belgrade , Serbia

Dubravka Bigović ,
Dubravka Bigović

Institute for Medicinal Plant Reasearch „Dr Josif Pančić“ , Belgrade , Serbia

Nebojša Noveski ,
Nebojša Noveski

Institute for Medicinal Plant Reasearch „Dr Josif Pančić“ , Belgrade , Serbia

Katarina Šavikin
Katarina Šavikin

Institute for Medicinal Plant Reasearch „Dr Josif Pančić“ , Belgrade , Serbia

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.


 

References

Andersen, Ø. M., & Markham, K. R. (2006). Flavonoids, Chemistry, Biochemistry and Applications.
FDA Inactive Ingredients Database for Approved Drug Products. (n.d.).
G., V., M., P., J., M., & S, S. (2012). Farmaceutska tehnologija I, Univerzitet u Beogradu, Farmaceutski fakultet.
Guideline on Stability Testing: Stability of Existing Active Substances and Related Finished Products (CPMP/QWP/122/02. (n.d.).
Handbook of Stability Testing in Pharmaceutical Development: Regulations, Methodologies, and Best Practices, Kim Huynh-Ba Pharmalytik. (2009). 59.
Jugoslovenska farmakopeja 2000, peto izdanje, Savezni zavod za zaštitu i unapređenje zdravlja, Savremena administracija. (2000).
Ovando, A. C., Hernandez, L. P., Hernandez, E. P., Rodriguez, J. A., & Galan-Vidal, C. A. (2009). Chemical studies od anthocyanins: A review. Food Chemistry, 113, 859–871.
prakse, S. D. (n.d.). Službeni glasnik RS".
Preformulation Chemical, H., Biological, Drugs, B., & Niazi, S. K. (2007). Pharmaceutical Scientist Inc.
Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products. (n.d.).
Tehničko-tehnološka dokumentacija Institut „Dr Josif Pančić“. (n.d.).
W.H.O. (2007). Quality assurance of pharmaceuticals. A compendium of guidelines and related materials (Vol. 1).
Zakon o lekovima i medicinskim sredstvima „Sl. (99 C.E.). In glasnik RS“, br.
(N.d.-a). In Guideline on Quality of Herbal Medicinal Products/Traditional Herbal Medicinal Products.
(N.d.-b). In Guideline on Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products (Doc. Ref.
(N.d.-c). In Guideline on Quality of Combination Herbal Medicinal Products / Traditional Herbal Medicinal Products (Doc.
(2009). In Handbook of Pharmaceutical Excipients.
(2010).

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