巴洛沙星片微生物限度检查方法验证试验研究

A method for validation of microbial limit tests of balofloxacin tablets

目的建立巴洛沙星片微生物限度检查法。方法制备1:10、1:100的供试液,采用离心沉淀与薄膜过滤的方法,来测定试验菌的回收率。结果供试品稀释100倍后,采用离心沉淀与薄膜过滤法,回收率即可达70%以上。结论可采用离心沉淀与薄膜过滤法消除巴洛沙星的抑菌活性,建立其微生物限度检查法。

Objective To set up a method for dermiming microbial limits in balofloxacin tablets.Methods 1：10,1：100 sample test solution were prepared,and the centrifugation,membrane filtration method were applied.The recovery was detected.Results When the sample dilution 100 times,the recovery was over 70% with the method of centrifugation and membrane filtration.Conclusion After method of centrifugation collection and membrane filtration,the amount of bacteria and controled bacteria can be determined in balofloxacin tablets.