复方硼砂溶液(稀)微生物限度检查法验证  

Validation of microbial limit test method of compound borax solution(diluted)

作　　者：刘全芳[1] 郑绍忠[1] 张婷[1] 

机构地区：[1]中国人民解放军第175医院厦门大学附属东南医院药剂科,福建漳州363000

出　　处：《安徽医药》2011年第8期963-964,共2页Anhui Medical and Pharmaceutical Journal

摘　　要：目的建立复方硼砂溶液(稀)的微生物限度检查法。方法依据《中国药典》2010年版二部附录XI J微生物限度检查法常规法进行验证试验。结果验证试验中试验组的加菌回收率均大于70%,控制菌检查可检出阳性菌,阴性菌不能检出。结论可以采用常规法进行复方硼砂溶液(稀)的微生物限度检查。Aim To establish a method for the microbial limit test of compound borax solution（diluted）.Methods A validation of microbial limit test method was conducted in accordance with routine method stated in the appendix of ＂Chinese Pharmacopoeia＂ 2010 Edition 2.Results The recoveries of test bacteria by routine method were more than 70%.The test bacteria were detected in the control bacteria test and were not detected in the negative control bacteria test.Conclusion Conventional method can be applied to Compound Borax Solution（diluted）in microbial limit test.

关 键 词：复方硼砂溶液 微生物限度检查法 方法验证 

分 类 号：R927.2[医药卫生—药学]