乙酰螺旋霉素片微生物限度检查方法验证

Verification of methodology on microbial limit test for acetylspiramycin tablets

目的建立乙酰螺旋霉素片微生物限度检查方法。方法采用常规法、离心沉淀集菌+薄膜过滤法进行方法验证。结果乙酰螺旋霉素片细菌计数采用离心沉淀集菌+薄膜过滤法,霉菌及酵母菌计数采用常规法,控制菌采用离心沉淀集菌+薄膜过滤法。结论确立了乙酰螺旋霉素片微生物限度检查方法 ,保证微生物限度检查方法的有效性。

Objective To provide methods of microbial limit tests for acetylspiramycin tablets.Methods Routine method and centrifugal sedimentation set bacteria＋membrane filtration method were used for the verification of methodology on acetylspiramycin tablets.Results Centrifugal sedimentation set bacteria＋membrane filtration method were suitable for acetylspiramycin tablets on bacterial count,and routine method were applied for acetylspiramycin tablets on fungi or yeasts count,centrifugal sedimentation set bacteria＋membrane filtration method were used for acetylspiramycin tablets on controlled bacteria.Conclusion Microbial limit tests for acetylspiramycin tablets are established,meanwhile the verification of methodology on the microbial limit test for acetylspiramycin tablets is assured.