双黄连口服液微生物限度检查法的验证

Validation of Microbial Limit Tests of Shuanghuanglian Oral Liquid

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。

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.