Mikrobiologische Prüfung pflanzlicher Arzneimittel
Analytik
Abstract
Microbiological Testing of Herbal Medicinal Products
Due to the natural microbial load of medicinal plants, the European Pharmacopeia has issued special provisions for the microbiological quality of herbal medicinal products for oral use and the test procedures that have to be used for their examination. Herbal medicinal products for oral use are classified in the categories A, B and C. These categories differ with respect to the requirements concerning the tests that have to be performed and the microbiological specifications that have to be met. The test methods are not fundamentally different from those used for the microbiological testing of non-herbal products, but some particularities have to be considered. Especially the methods for the quantification of E. coli and bile-tolerant gram-negative bacteria may cause problems in practice. Considering the method-suitability tests, the basic microburden of the herbal products and often a very specific antimicrobial activity are particularly challenging.
The European perceptive is frequently not accepted by non-European authorities as the US FDA or the Chinese FDA and may cause irritations during inspections. In Europe, the focus on data integrity issues is increasing.
Zusammenfassung
Aufgrund der natürlich hohen Keimbelastung von Arzneipflanzen gibt es im Europäischen Arzneibuch Sonderanforderungen an die mikrobiologische Qualität von oralen pflanzlichen Arzneimitteln. Pflanzliche Arzneimittel zum Einnehmen werden in die Kategorien A, B und C eingeteilt. Die einzelnen Kategorien variieren hinsichtlich der Anforderungen an die durchzuführenden Prüfungen und der einzuhaltenden Akzeptanzkriterien. Die Prüfmethoden unterscheiden sich zwar nicht grundsätzlich von denen, die bei der mikrobiologischen Prüfung nicht pflanzlicher Produkte zum Einsatz kommen, es sind
