双黄连口服液微生物限度检查法的验证

目的:验证双黄连口服液微生物限度检查法。方法:分别采用常规法、培养基稀释法及薄膜过滤法测定双黄连口服液对大肠埃希菌等4种试验菌株的回收率。结果:双黄连口服液具有抑菌活性,常规法无法真实反映出溶液受污染的情况。采用薄膜过滤法和培养基稀释法,试验菌株回收率均符合要求,但薄膜过滤法回收率显著高于培养基稀释法。结论:对双黄连口服液进行微生物限度检查应优先采取薄膜过滤法。

Validation of Microbial Limit Tests of Shuanghuanglian Oral Liquid

OBJECTIVE:To validate the microbial limit tests of Shuanghuanglian oral liquid.METHODS:The recovery rates of 4 kinds of test organisms including E.coli treated by Shuanghuanglian oral liquid were detected by routine method,culture medium dilution method,and membrane-filter procedure respectively.RESULTS:Shuanghuanglian oral liquid was found to be of bacteriostatic action.The contamination of solution couldn't be detected by routine method.The recovery rate of the test organisms detected by membrane-filter procedure was higher than by culture medium dilution method,but the recovery rates in both methods were all up to the requirement.CONCLUSION:Membrane-filter procedure should be considered preferentially in performing microbial limit test for Shuanghuanglian oral liquid.