藿香正气胶囊微生物限度检查法验证

为建立藿香正气胶囊微生物限度检查验证方法,采用多种阳性菌作为对照菌,采用回收率试验测定其抑菌成分对微生物限度检查的影响.根据回收率试验结果,藿香正气胶囊抑菌成分对微生物限度检查影响较大,通过系统性设置试验,表明薄膜过滤法、离心沉淀薄膜过滤法能消除其影响,但薄膜过滤法中枯草芽孢杆菌回收率相对较低,抑菌成分消除不彻底,而离心沉淀集菌薄膜过滤法能完全、彻底消除其抑菌作用.

Validation of Microbial Limit Test of Huoxiangzhengqi Capsule

A variety of Gram-positive bacteria are used as the control bacteria. The recovery test determines the impact of antifungal composition on microbial limit tests. According to the results of the recovery test, Huoxiangzhengqi capsule antifungal composition has great effect on the microbial limit test. Through the systematic set to test, the results show that the membrane fihration, centrifugation and membrane filtration method can eliminate its influence. But in the membrane filtration method, bacillus subtilis recovery rate is relatively low and antibacterial ingredients can＇ t be eliminated thoroughly. The centrifugal sedimentation and membrane filtration method can eliminate the antimicrobial effect completely and thoroughly.