盐酸特比萘芬乳膏的释放度考察  

Study on release of terbinafine hydrochloride cream

作　　者：何一鸣[1] 张蜀[1] 邓红[1] 陈英和[1] 崔曰新 何卓儒 

机构地区：[1]广东药学院药物研究所,广东省药物新剂型重点实验室,广州510006

出　　处：《中国新药杂志》2015年第4期462-465,469,共5页Chinese Journal of New Drugs

摘　　要：目的:建立盐酸特比萘芬乳膏释放度检查法。方法:采用改良的桨碟法进行盐酸特比萘芬乳膏的体外释放度试验,以超高效液相色谱法测定其释放度;并用f2相似因子法评价自制乳膏与兰美抒体外释放曲线的相似性。结果:乳膏基质及释放介质对测定无干扰,平均回收率为101.1%,RSD值为0.33%(n=9)。f2因子分别为45.5,37.8,58.7。结论:本法简便、重现性好,为建立盐酸特比萘芬乳膏的体外释放度检查法提供依据。自制乳膏中有一批与兰美抒释放行为相似。Objective：To develope the release test method of terbinafine hydroehloride cream. Methods： The improved paddle over disk method was used to study the in vitro release of terbinafine hydrochloride cream. And an ultra performance liquid chromatography method was used to determine the content of terbinafine hydrochloride. The accumulative release percentage was obtained,and similarity factor f2 was used to compare the in vitro release between selfprepared creams and the commercial product Lamisil. Results：The cream base and test medium had no interference with the experiment. The average recovery and RSD were 101.1% and O. 33% （n = 9） , respectively. The f2 were 37.8,45.5, and 58.7 for the three batches of self-prepared creams, respectively. Conclusion：This method is convenient and reproducible, which provides a basis for developing the release test method of terbinafine hydrochloride cream. There was similarity in the in vitro release behavior between one batch of self-pre- pared cream and the commercial product Lamisil.

关 键 词：盐酸特比萘芬乳膏 释放度 桨碟法 f2相似因子 

分 类 号：R978.5[医药卫生—药品]