银芩胶囊微生物限度检查方法适用性试验的研究  

Studies on Suitability Test of the Method of Microbial Limit Tests of Yinqin Capsules

作　　者：赵加强 周荣光 游春燕[2] 

机构地区：[1]昆药集团股份有限公司,昆明650106 [2]中国药科大学,南京210009

出　　处：《海峡药学》2016年第6期43-45,共3页Strait Pharmaceutical Journal

基　　金：云南省科技计划项目(2013FZ260)

摘　　要：目的建立银芩胶囊微生物限度检查方法。方法按照《中国药典》2015版要求,对银芩胶囊需氧菌、霉菌及酵母菌的计数方法和控制菌的检查方法进行适用性试验。结果采用常规法(1m L/皿,10^(-1))检测霉菌及酵母菌,采用稀释法(1m L/皿,10^(-2))检测需氧菌,回收试验比值在0.5~2之间。结论可采用平皿计数法对银芩胶囊进行微生物限度检查。OBJECTIVE To establish a microbial limits testing methods for Yinqin capsules. METHODS Referring to Chinese Pharmacopoeia（ 2015 edition）,the suitability test of counting method of aerobic bacteria,mold and yeast,and the suitability test of control bacteria examination method for Yinqin capsules was done in accordance with the conventional method and the dilution method. RESULTS Counting mold and yeast by the general method（ 1m L/plate,10^-1）,and counting aerobic bacteria by the dilution method（ 1m L/plate,10^-2）,their rates of the recovery test were in the range of 0. 5 ~ 2. CONCLUSION The plate counting method could be used for microbial limit tests of Yinqin capsules.

关 键 词：银芩胶囊 微生物限度检查 适用性试验 

分 类 号：R927.12[医药卫生—药学]