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目的:考察2005年版中国药典微生物限度检查方法学验证试验中加菌时间点的合理性。方法:对药典中提供的非水溶性供试品的萃取法以及具抑菌活性供试品的低速离心沉淀法进行回收率试验。结果:8种菌株采用萃取法进行前处理后,有3种菌株几乎可以100%回收,另外5种菌株的回收率约为70%左右;采用离心沉淀法前处理后,白色念珠菌回收率均低于30%,黑曲霉回收率也在30%左右,其余6种菌株,如样品中不含辅料或含有可溶性辅料,则对其回收率影响不大,如样品中含有不溶性辅料,则其回收率均低于70%。结论:2005年版中国药典微生物限度检查方法学验证试验中加菌时间点应该修订。
OBJECTIVE: To investigate the rationality of the time point of adding bacteria in the verification test of the 2005 edition of Chinese Pharmacopoeia. Methods: The recovery test of the non-water-soluble extract provided by the pharmacopoeia and the low-speed centrifugal precipitation method with the antibacterial activity of the test product were carried out. Results: After the eight strains were pretreated by extraction method, three strains could be recovered almost 100%, and the recovery rate of the other five strains was about 70%. After pretreatment with centrifugal precipitation method, the recoveries of Candida albicans Less than 30%, Aspergillus niger recovery rate is about 30%, the remaining six strains, such as samples without excipients or soluble excipients, the recovery rate is not affected, if the sample contains insoluble excipients, the recovery Rate of less than 70%. Conclusion: The 2005 edition of Chinese Pharmacopoeia microbial limit test methodological validation test should be amended at the time points.