目的:建立黄枳胶囊微生物限度检查方法。方法:参考中国药典2005年版进行试验,并对所采用的方法进行方法学验证。结果:常规法对照用阳性菌金黄色葡萄球菌、枯草芽孢杆菌、大肠埃希菌的回收率小于70%,薄膜过滤法回收率均大于70%。结论:薄膜过滤法能有效地去除黄枳胶囊的抑菌活性,该法可行性强,能达到检测目的。 Objective: To establish a microbial limit test method for Huangqi Capsule. Methods: Experiments were conducted with reference to the 2005 edition of the Chinese Pharmacopoeia and methodological validation was performed on the methods used. RESULTS: The recoveries of the positive control Staphylococcus aureus, Bacillus subtilis, and Escherichia coli were less than 70%, and the membrane filtration recovery was greater than 70%. Conclusion: The membrane filtration method can effectively remove the antibacterial activity of Huangqi Capsule. The method is feasible and can achieve the purpose of detection.