中国执业药师Issue(5)：21-23,27,4.DOI:10.3969/j.issn.1672-5433.2015.05.005
小儿启脾片微生物限度检查方法验证研究
Research on Method Validation of Microbial Limit Test for Pediatric Qipi Tablets
颜明 1王东兴 2王艳美 3王宝庆1
作者信息
- 1. 牡丹江市食品药品检验检测中心，黑龙江 牡丹江 157011
- 2. 牡丹江心血管医院
- 3. 牡丹江灵泰药业股份有限公司
- 折叠
摘要
Abstract
ABSTRACTObjective:To validate the method of microbial limit test for pediatric qipi tablets.Methods:The method of microbial limit test set forth in the appendixⅧC of theChinesePharmacopoeiaof 2010 edition was adopted to determine the microbial limit of pediatric qipi tablets. Through three independent parallel tests, the recov-ery of each test using five kinds of bacteria for validation was calculated respectively. In order to verify the control bacteria,E.coliandStaphylococcusaureuswere cultured and observed at the same environment.Results:The re-covery of five kinds of bacteria was all higher than 70%, and bacteria for validation were detected in the test group, but no growth was observed in the negative control group.Conclusion:The conventional method can be used for the microbial limit test of pediatric qipi tablets.关键词
小儿启脾片/微生物限度检查/方法学验证Key words
Pediatric Qipi Tablets/Microbial Limit Test/Methodology Validation引用本文复制引用
颜明,王东兴,王艳美,王宝庆..小儿启脾片微生物限度检查方法验证研究[J].中国执业药师,2015,(5):21-23,27,4.
