头孢克肟分散片微生物限度检查的方法学验证.PDFVIP

头孢克肟分散片微生物限度检查的方法学验证 * 肖全英，江劲，吴丽梅，曾环想 ，李小清，刘芳(深圳致君制药有限公司，广东 深圳 518110) 摘要：目的 建立头孢克肟分散片的微生物限度检查方法，并对其进行方法学验证。方法 细菌计数采用薄膜过滤法， 霉菌及酵母菌计数采用平皿法，根据中国药典 2005 年版二部分别使用 5 种实验菌验证。通过 3 次独立的平行试验，分别 计算各试验菌每次试验的回收率。控制菌检查采用薄膜过滤法。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 2005 版验证试验的基本要求。结论 本品的微生物限度检查方法有 效可行，可用于头孢克肟分散片的微生物限度检查。 关键词：头孢克肟分散片；微生物限度检查；方法学验证 中图分类号：R927.33 文献标志码：B 文章编号：1007-7693(2010)08-0732-04 Establishment and Validation of Methodology for Microbial Limit Test of Cefixime Dispersible Tablets * XIAO Quanying, JIANG Jing, WU Limei, ZENG Huanxiang , LI Xiaoqing, LIU Fang (Shenzhen Zhijun Pharmaceutical Co. Ltd., Shenzhen 518110, China) ABSTRACT: OBJECTIVE To establish a method for microbial limit test of cefixime dispersible tablets, and carry out the verification of methodology. METHODS The method for microbial limit test of cefixime dispersible tablets was established by a membrane filtration method of total aerobic microbial count and the plate-count method of the total yeasts and moulds and a membrane filtration method of control of bacterial and the method validation was performed according to the Chinese Pharmacopoeia 2005 version. Negative product control and negative diluent control were proceeded with the test of the product. 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 2005 version. CONCLUSION The method can be used in microbial limit test of cefixime dispersible tablets. KEY WORDS: cefixime dispersible tablets; microbial limit test; validation 头孢克肟(cefixime)是第三代头