氧氟沙星栓微生物限度检查方法探讨

Study on the microbial limit test method for ofloxacin suppositories

目的建立氧氟沙星栓微生物限度检查方法并验证。方法采用低速离心、薄膜过滤中和法联合法进行细菌计数测定,采用培养基稀释法进行真菌计数测定,采用薄膜过滤中和法进行控制菌检查。结果确立的方法可以较好的溶解样品,使易于过滤,降低冲洗量,验证结果符合要求。结论该方法适合氧氟沙星栓的检查。

Objective To establish a method for microbial limit test of ofloxacin suppositories.Methods Using lowspeed centrifugation,membrane filtration method and combined method determination of bacterial counts,using the medium for fungal counts measured dilution method,using membrane filtration and method to control bacteria in check.Results Established method cound better dissolve the sample,so easy to filter,reduce the flushing volume,verify results meet the requirement.Conclusion The method is suitable for microorganism limit test of ofloxacin suppositories.