祛痰合剂的微生物限度检查方法验证  

Validation of microbial limit tests of expectorant mixture

作　　者：李国成[1] 刘春霞[1] 余晓霞[1] 

机构地区：[1]中山大学孙逸仙纪念医院,广东广州510120

出　　处：《中国医院药学杂志》2011年第3期199-201,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的:建立祛痰合剂的微生物限度检查法。方法:测定祛痰合剂对大肠埃希菌等5种试验菌的回收率,通过观察回收率来确定适宜的检验方法,以及对控制菌(大肠埃希菌)的检查方法进行验证。结果:用常规法检查本品的细菌数、霉菌数及酵母菌数,其试验菌回收率达到70%以上。用常规法检查本品的大肠埃希菌,其试验组呈阳性反应,阴性菌对照组呈阴性反应。结论:使用上述方法可以验证祛痰合剂在试验条件下的抑菌作用,从而顺利地检出该品种所污染的各种微生物,通过上述实验为祛痰合剂的微生物限度检查提供了科学的方法和依据。OBJECTIVE To establish a method of microbial limit test for expectorant mixture. METHODS Determination of expectorant mixture of Escherichia coli bacteria such as five kinds of tests the recovery rate, by observing the recovery rate to determine the appropriate testing methods, as well as control bacteria （Escheriehia coli） and inspection methods for authentica- tion. RESULTS Check this product with the conventional method the number of bacteria, fungi and yeast count the number, the test bacteria recovery rate over 70%. Check this product with the conventional method of Escherichia coli, the test group showed positive results, negative bacteria group was negative. CONCLUSION Using the above method can expectorant mix- ture under the conditions of the test antimicrobial effect, thereby successfully detected the strain of the pollution of various mi- cro-organisms, through the above experiment expectorant mixture of microbial limit provides a scientific method and basis.

关 键 词：祛痰合剂 微生物限度检查 方法学验证 

分 类 号：R944[医药卫生—药剂学]