4种大环内酯类药物微生物限度检查方法验证

Verirification of Methodology on Microbial Limit Tests for Four Macrolides

目的建立4种大环内酯类药物的微生物限度检查方法。方法采用常规法、培养基稀释法、离心集菌薄膜过滤法进行方法验证。结果确立了4种大环内酯类药物的微生物限度检查方法。结论真菌可用常规法进行微生物限度的霉菌和酵母菌菌落数检查;可用离心集菌薄膜过滤法进行微生物限度的细菌菌落数检查。

Objective To establish the methods of the microbial limit tests for four macrolides. Methods Routine method,medium diluting method and centrifuging and filtering method were used for the verification of methodology on 4 macrolides. Results Microbial limit tests for 4 macrolides were established. Conclusion All of the 2 strains of fungus are more than 70 percent using routine examination method. Centrifuging and filtering method is available for 4 macrolides.