不同厂家生产的西洛他唑片微生物限度检查方法验证  

The Validation Method of Microbial Limit Tests for Different Companies of Cilostazol Tablets

作　　者：钱文静[1] 张玫[1] 

机构地区：[1]江苏省药品检验所,南京210008

出　　处：《中国药品标准》2011年第1期50-53,共4页Drug Standards of China

摘　　要：目的:建立不同厂家的西洛他唑片微生物限度检查方法的验证。方法:菌落计数方法的验证:一厂家采用常规平皿法,另一厂家采用霉菌及酵母菌数测定,为培养基稀释法,每皿0.2 mL,细菌数测定为低速离心加薄膜过滤法,即取1∶10的低速离心供试液10 mL稀释后进行薄膜过滤,用300 mL冲洗液分6次冲洗,泵速为150 r.min-1。结果:不同厂家生产的相同品种、相同规格的西洛他唑片,微生物限度检查方法验证的结果完全不同。结论:处方不同,可以影响药品微生物限度检查的结果。Objective： To establish a method for determination of microbial limit test in different companies of Cilostazol Tablets. Methods： The validation of the colony-count methods ： One is the normal plate count method, the other is that the mold and yeast colony count of other companies was used by the medium dilution method, 0. 2 mL for each plate. The bacteria colony count was used by the low-speed centrifugation and membrane filtration. Got 10 mL of 10% of the sample that had been low-speed centrifuged, then rinsed the membrane six times after the filtration. The total volume of the rinse solution was 300 mL and the speed of the pump was 150 r·min^-1 min . Results： The Cilostazol Tablets of the same kind and specification but different companies had different methods of microbial limit tests. Conclusions： Different prescription could influence the results of medicine microorganism limit tests.

关 键 词：西洛他唑片 微生物限度 平皿法 薄膜过滤法 

分 类 号：R927[医药卫生—药学]