【摘要】 目的 建立盐酸坦洛新缓释片微生物限度检查方法[1]，并对该法的有效性进行评价。方法 采用2种乳化方法，制备适宜微生物检测的供试液。以对照菌回收为主要内容，用样本组和对照组之间的回收率对有效性进行评价。结果 供试液制备方法中第2种方法制得均匀细腻的混悬液，所采用的乳化剂、稀释剂不干扰微生物的检出，方法验证结果符合《中国药典》[1]规定。结论 通过上述试验确定了盐酸坦洛新缓释片微生物限度检查方法。

    【关键词】 微生物限度检查法;有效性;验证

    Experimental study on microbial limit tests and validations of tamsulosion hydrochloride sustained release tables

    XANG Dong,LI Ye,FAN Bing.Yunnan Institute for Food and Drug Control, Kunming 650011,China

    【Abstract】 Objective To establish and validate to the method for the microbial limit tests of tamsulosion hydrochloride sustained release tablets.Methods Used for two kind of emulsified methods preparation testing liquid. The validation have been tested by microbial recovery and the availability was estimated by the ratio of recovery from the test group to the control group.Results Testing liquid emulsified by the second method is fine-even. The emulsifier and the diluent did not influence the tests. The result of validation conforms to the Chinese pharmacopoeia tallies.Conclusion The method for the microbial limit tests of tamsulosion hydrochloride sustained release tablets was established. ......