当归活血液微生物限度检查的方法学验证

Method validation for microbial limit test of Angelica Huoxue liquid

目的建立当归活血液的微生物限度检查方法。方法按照《中国药典》2010年版一部附录ⅩⅢC中方法对微生物限度和控制菌进行检查,以5种试验菌的回收率对检验方法的有效性进行验证和确认。结果采用常规方法对当归活血液进行微生物限度检查时,发现枯草芽孢杆菌在3次平行试验中的回收率均低于70%,其他4种试验菌回收率都高于70%;培养基稀释法(1∶10的样品稀释液,0.5 m L/皿)对5种试验菌的回收率均超过70%;采用常规法可在试验组检出控制菌大肠埃希菌。结论本文建立的培养基稀释法可用于当归活血液的微生物限度检查,而控制菌大肠埃希菌的检查可采用常规法进行。

Objective To perform the method validation of the microbial limit test for Angelica Huoxue liquid.Methods A microbial limits method of Chinese Pharmacopeia（2010 edition） part one appendix ⅩⅢ C was used to detect the microbial limit of Angelica Huoxue liquid. The validation was evaluated with the recoveries of five test bacteria. Results With routine method,the recovery ratios were higher than 70% except Bacillus subtilis. However,with culture medium dilution（1∶ 10 sample solution,0. 5 m L / dish）,all the recovery ratios of the five test bacteria were above 70%. The control bacteria Escherichia coli in experimental group could be detected by the routine method. Conclusion This culture medium dilution method could be used for the microbial limit examination for Angelica Huoxue liquid,and the control bacteria of Escherichia coli could be detected by the routine method.