抗敏止痒霜微生物限度检查方法研究  

Research on the Microbial Limit Test for the Anti-allergic and Antipruritic Cream

作　　者：胡泽锴 毛腾霄 

机构地区：[1]成都市食品药品检验研究院,成都610045

出　　处：《海峡药学》2016年第11期70-72,共3页Strait Pharmaceutical Journal

摘　　要：目的建立抗敏止痒霜的微生物限度检查方法,并对其进行方法学方面的验证。方法按照《中国药典》2015年版的规定,采用常规法和培养基稀释法进行微生物限度检查方法验证。结果采用常规法检查,供试品对大肠埃希菌、金黄色葡萄球菌、枯草芽孢杆菌3种试验菌的回收率均远高于70%,采用稀释法对白色念珠菌、黑曲霉2种试验菌的回收率均在90%以上,采用常规法能正常检出控制菌。结论本文建立了抗敏止痒霜的微生物限度检查方法,可有效控制其质量。OBJECTIVE To establish a method of microbial limit tests for the Anti Allergic and Antipruritic Cream. METHODS According to the appendices volume Ⅱ of Chinese Pharmacopeia （ edition 2015 ） , routine method and medium dilution method were used for the test of Anti Allergic and Antipruritic Cream. RESULTS The recoveries of Escherichia toll, Staphylococcus aureus and Bacillus subtilis were much more than 70% when we used routine method. In medium dilution method, recoveries of Candida albicans and Aspergillus niger were higher than 90%. When we used routine method, the quality of control germ check was credible. CONCLUSION The method of microbial limit test for Anti Allergic and Antipruritic Cream was established, which may be used for its quality control.

关 键 词：抗敏止痒霜 微生物限度检查 常规法 稀释法 

分 类 号：R927[医药卫生—药学]