中国执业药师Issue(8)：10-13,4.DOI:10.3969/j.issn.1672-5433.2015.08.003
碘乳康口服溶液微生物限度检查方法学验证
Methodology Validation of Microbial Limit Test for Dianrukang Oral Solution
张广求 1刘文 1田祥学2
作者信息
- 1. 黄冈市中心医院药剂科，湖北 黄冈 438000
- 2. 黄冈市食品药品监督检验中心
- 折叠
摘要
Abstract
Objective:To establish the method of microbial limit test for dianrukang oral solution.Methods:According to the method of microbial limit test set forth in the Volume II Appendix ofChinaPharmacopoeia(2010 edition), the test method validations were carried out for bacteria, mold, yeast and the control bacteria for dianrukang oral solution. For each test three parallel experiments were performed independently and the recovery rate of each tested organism was calculated.Results:Using the conventional method for the tests of five kinds of positive control strains, the recovery rates ofStaphylococcusaureus,Escherichiacoli,Bacillussubtilis,Candida albicansandAspergillusnigerwere all less than 70%, using medium dilution method(0.5 mL/plate), the recovery rates of the above mentioned strains were all greater than 70%, and the control bacteria ofEscherichiacolican be detected by conventional method.Conclusion:In the microbial limit test of dianrukang oral solution, culture medium dilution method(0.5 mL/plate)can be used for bacteria , mold and yeast counting and the conventional method can be used for the test ofEscherichiacoli.关键词
碘乳康口服溶液/微生物限度/方法学验证试验/回收率Key words
Dianrukang Oral Solution/Microbial Limit/Methodology Validation Test/Recovery Rate引用本文复制引用
张广求,刘文,田祥学..碘乳康口服溶液微生物限度检查方法学验证[J].中国执业药师,2015,(8):10-13,4.
