头孢丙烯微生物限度检查方法的验证

目的 建立头孢丙烯原料的微生物限度检查方法,并对其进行方法学验证。方法 按中国药典2010年版方法对3 个批号的头孢丙烯原料进行微生物限度检查方法验证。细菌的计数方法和控制菌检查均采用低速离心-薄膜过滤-酶中和联用法；霉菌和酵母菌计数采用平皿法。结果 各试验菌的回收率均高于70%,稀释液回收率也均高于70%,控制菌检查具有专属性,满足中国药典2010 版验证试验的要求。结论 本品的微生物限度检查方法有效可行,可用于头孢丙烯原料的微生物限度检查。

Establishment and Validation of Methodology for Microbial Limit Test of Cefprozil APIs

OBJECTIVE To establish a method for microbial limit test of cefprozil APIs, and carry out theverification of methodology. METHODS According to the method of the 2010 Chinese Paharmacopoeia, microbial limitexamination of three batches of cefprozil APIs were studied.Low speed centrifuge,membrane filtration and enzyme neutralization method were used with count of bacterium and pathogenic bacteria test. The plate method was used with counts mold and yeasts. RESULTS The recoveries above 70% were obtained when comparing the product challenge to its corresponding inoculum control, and no growth was observed in the negative diluent controls. The method could pass the validation test of Chinese pharmacopoeia 2010 version. CONCLUSION The method can be used in microbial limit test of cefprozil APIs.KEY WORDS: cefprozil APIs; microbial limit test; validation