《中国药典》2010年版和2015年版大肠埃希菌检查方法的比较研究  

Comparative study of Escherichia coli test method by Chinese Pharmacopoeia 2010 and Chinese Pharmacopoeia 2015

作　　者：陈志禹 席时东 

机构地区：[1]宁波市药品检验所,浙江宁波315040

出　　处：《中国卫生检验杂志》2016年第6期813-815,共3页Chinese Journal of Health Laboratory Technology

摘　　要：目的比对《中国药典》2010年版和2015年版大肠埃希菌检查方法在培养基、检测方法和检测灵敏度上的差异。方法 14个生产企业24批次的八珍系列制剂(丸剂、颗粒剂、胶囊剂、片剂、口服液),分别按《中国药典》2010年版和2015年版的检测方法进行大肠埃希菌检查方法学验证。18个生产企业125批次的八珍系列制剂采用两版药典方法进行大肠埃希菌检查。结果两版药典均可采用直接接种法对八珍系列制剂进行大肠埃希菌检查,结果均符合规定。2010年版方法检验125批次样品的MUG和Indole均为阴性,2015年版方法检验结果有7个样品在麦康凯琼脂平板上检出微生物,经生化鉴定均不是大肠埃希菌。结论《中国药典》2010年版方法简便省时易出现漏检,2015年版方法操作步骤多耗时,检出率高,《中国药典》2015年版大肠埃希菌检查方法对微生物鉴定提出了更高的要求。Objective To study the differences of the culture media,test method and detection sensitivity in the test of Escherichia coli（ E. coli） by Chinese Pharmacopoeia（ Ch. P） 2010 and Ch. P 2015. Methods The validation of E. coli test methods of 24 batches Bazhen preparations（ pills,granules,capsules,tablets,oral liquid） from 14 manufacturers were conducted,according to Ch. P 2010 and Ch. P 2015. The E. coli test on 125 batches of Bazhen preparations from 18 manufacturers were conducted after method validation. Results The direct inoculation method was applied to both Ch. P 2010 and Ch. P 2015. All of the Bazhen preparations meet test requirements of Ch. P 2010 and Ch. P 2015. The test of MUG and Indole were negative according to Ch. P 2010 method for all of the 125 batches tested. There were microorganism grown on 7 Mac A plates,which were identified to not be E. coli. Conclusion The Ch. P 2010 method was time saving,but might have higher missing rate; while the method of Ch. P 2015 was time costing but with higher detection sensitivity. The Ch. P 2015 raises higher request for the microbe identification.

关 键 词：《中国药典》2010年版 《中国药典》2015年版 大肠埃希菌检查 八珍系列制剂 

分 类 号：R286.0[医药卫生—中药学]