盐酸特比萘芬乳膏微生物限度检查方法学研究  

Methodology Study of Microbial Limit Test of Terbinafine Hydrochloride Cream

作　　者：蔡金莲 CAI jin-lian(Foshan center for food and drug control,Foshan 528000,China)

机构地区：[1]佛山市食品药品检验检测中心,广东佛山528000

出　　处：《海峡药学》2020年第8期71-74,共4页Strait Pharmaceutical Journal

摘　　要：目的建立盐酸特比萘芬乳膏的微生物限度检查方法。方法根据《中国药典》2015年版的规定,采用平皿法、薄膜过滤法进行方法验证。结果需氧菌总数、霉菌和酵母菌总数采用液体石蜡萃取样品后薄膜过滤(冲洗1000mL/膜),各试验菌的回收率可达到药典的要求;用常规法进行控制菌的检查。结论可用该法进行盐酸特比萘芬乳膏的微生物限度检查。OBJECTIVE To establish a microbial limit test method for terbinafine hydrochloride cream.METHODS Plate method and membrane filtration method were used for the verification of methodology on terbinafine hydrochloride cream according to Chinese Pharmacopoeia(2015).RESULTS Total Aerobic Bacteria and Total number of molds and yeasts could be tested with membrane filtration method(1000mL/membrane)after extracting the sample by liquid paraffin,all control bacteria were tested with routine method.CONCLUSION The microbial test methodology of terbinafine hydrochloride cream was established.

关 键 词：盐酸特比萘芬乳膏 微生物限度 液体石蜡萃取 薄膜过滤 

分 类 号：R927[医药卫生—药学]