复方去煤液微生物限度检查及方法学验证

目的:建立复方去煤液的微生物限度检查方法。方法:按照《中国药典》2010年版的规定,采用常规法、培养基稀释法和薄膜过滤法进行复方去煤液微生物限度检查的方法学验证。结果:复方去煤液对细菌有较强的抑制作用,采用培养基稀释法和薄膜过滤法可有效地消除复方去煤液的抑菌活性。结论:用培养基稀释法和薄膜过滤法进行复方去煤液的微生物限度检查,可以客观地反映复方去煤液中微生物的污染状况,以达到检测目的。

Microbial Limit Test and Methodology Validation of Fufang Qumeiye

Objective: To establish a method for the microbial limit test of Fufang Qumeiye. Methods: According to the Chinese Pharmacopoeia 2010 edition, the routine method, culture medium dilution method and membrane filtration method were performed for microbial limit test methodology validation of Fufang Qumeiye. Results: Fufang Qumeiye showed inhibition effect on the bacteria, which could be eliminated by culture medium dilution method and membrane filtration method. Conclusion: Culture medium dilution method and membrane filtration method applied for microbial limit test can objectively reflect the status of microbial contamination in Fufang Qumeiye so as to meet the destination of examination.