建立泰乐(盐酸特拉唑嗪胶囊)微生物限度的检查方法  

Method Development of Microbial Limit Test for Taile(Terazosin Hydrochloride Capsules)

作　　者：周蓉 陈小燕 余晓燕 刘卫 叶红芳 

机构地区：[1]扬子江药业集团江苏制药股份有限公司,江苏泰州225321

出　　处：《中国医药指南》2017年第28期33-35,共3页Guide of China Medicine

摘　　要：目的建立泰乐(盐酸特拉唑嗪胶囊)1 mg的微生物限度检查新方法。方法参考《中国药典》2015版,采用平皿法以及薄膜过滤法(冲洗量300mL),接种6种试验菌测定其回收率。结果适用性试验中各试验菌的回收率均在0.5~2。结论该方法可行有效,能用于泰乐(盐酸特拉唑嗪胶囊)1 mg的微生物限度检查。Objective To establish a method for microbial limit of Taile（Terazosin Hydrochloride Capsules） 1 mg. Method with reference to ChP 2015, the recovery rate of 7 kinds of test bacteria were determined by plate method and membrane filtration method（300 mL）. Results In validation tests, recoveries of various types of bacteria were between 0.5 and 2. Conclusion The method is feasible and effective and can be used for microbial limit test of Taile（Terazosin Hydrochloride Capsules） 1 mg.

关 键 词：泰乐(盐酸特拉唑嗪胶囊) 适用性试验 微生物限度检查法 

分 类 号：R-33[医药卫生]