盐酸特比萘芬乳膏微生物限度检查法的方法学研究

Methodological Study of Microbial Limits Testing for Terbinafine Hydrochloride Cream

目的建立盐酸特比萘芬乳膏的微生物限度检查方法。方法采用《中国药典》2010年版二部微生物限度检查法对盐酸特比萘芬乳膏进行方法验证。结果盐酸特比萘芬乳膏微生物限度细菌检查可采用薄膜过滤法(300mL.膜-1),霉菌和酵母菌检查宜采用薄膜过滤法(500mL.膜-1),控制菌采用常规法。结论该法可用于盐酸特比萘芬乳膏的微生物限度检查。

Objective To establish a microbial limits testing method for Terbinafine Hydrochloride Cream. Methods The methods of microbial limit test in Appendices VolumeⅡof Pharmacopoeia of People＇s Republic of China （Edition 2010） were adopted to validate the testing results of Terbinafine Hydrochloride Cream. Results Membrane-filter method （300 mL per membrane） could be used for the microbial limit detection of Terbinafine Hydrochloride Cream; membrane-filter method （500 mL per membrane） was the best one for the detection of fungus and yeast fungus; routine method could be used for the detection of control bacteriae. Conclusion The method can be used for the microbial limits testing of Terbinafine Hydrochloride Cream.