小儿止咳合剂微生物限度检查  

Microbial limit test for Xiaoer Zhike Mixture

作　　者：张凤羽[1] 郑兆银 

机构地区：[1]天津市静海县药品检验所,天津市301600

出　　处：《天津药学》2014年第2期34-35,共2页Tianjin Pharmacy

摘　　要：目的:建立小儿止咳合剂微生物限度检查方法并验证。方法:按《中国药典》微生物限度检查法,通过常规法和培养基稀释法测定小儿止咳合剂对五种验证菌株的回收率,并对控制菌检查方法进行验证。结果:常规法试验对大肠埃希菌、白色念珠菌、黑曲霉无抑制作用,而对金黄色葡萄球菌、枯草芽孢杆菌有较强抑制作用;采用培养基稀释法,使金黄色葡萄球菌、枯草芽孢杆菌的回收率均大于70%。控制菌检查采用常规法。结论:本方法能准确检测出小儿止咳合剂中污染菌。Objective ： To establish a microbial limit test method for Xiaoer Zhike Mixture. Methods ： In accordance with Chinese Pharmacopoeia 2010th edition,the recovery of five tested strains treated with Xiaoer Zhike Mixture was determined by the plating method and the medium dilution method. The test method for the control bacteria was verified. Results ： For plating method, Xiaoer Zhike Mixture, which had no inhibitory action on escherichia coli, canidia albicans and aspergillus niger, had potent bacteriostatic action on staphylococcus aureus and bacillus subtilis. For the culture medium dilution method, the recovery rate of staphylococcus aureus and bacillus subtilis was over 70%, respectively. Conclusion： The contaminated bacteria in Xiaoer Zhike Mixture can detected accurately by the method established in this study.

关 键 词：微生物限度检查法 验证 培养基稀释法 

分 类 号：R927.11[医药卫生—药学]