Pharmaceutical quality, Standardisation and Normalisation of Phytomedicines

Author(s): Czygan, F. -C., Franz, G., Ihrig, M., Nahrstedt, A., Sprecher, E.

Abstract: For the authorization of phytomedicines in Germany Legislation demands proof of therapeutical and pharmaceutical quality. Proof of efficacy and safety of a drug must always be reproducable. Phytomedicines due to the definition of the BGA are complex mixtures of substances, the starting material varies largerly in its content of the active ingredients. By the manufacturing process additional alterations of the active ingredients may be induced. Therefore the demands of the legislator can only be met by an adequate comprehensive quality control. The control includes the standardisation of the starting material, the manufacturing process as well as standardisation of the final product. On the basis of the demands of the DAB 10 the problems of such procedures are discussed using hawthorn fluid extract and Aesculus dry extract as examples. It points at the necessity of a reproducable specification for each drug-preparation.

Keyword(s): Autorization of phytomedicines

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