不同厂家盐酸舍曲林片的溶出度比较

Comparative Study on Dissolution Profiles of Sertraline Hydrochloride Tablets from Different Manufacturers

评价不同厂家盐酸舍曲林片的溶出特性。采用《中国药典》2015年版收载的溶出度测定法,考察了3个厂家盐酸舍曲林片的溶出度;用f_2相似因子法对溶出曲线进行相似性比较,并以weibull方程拟合溶出度参数。结果 3个厂家盐酸舍曲林片的体外溶出度均符合药典规定,但国产制剂与进口制剂的溶出参数存在差异(P<0.05)。不同厂家的盐酸舍曲林片的溶出参数存在差异,药品采购和临床用药时应加以注意。

To compare the in vitro dissolution profile of sertraline hydrochloride tablets from different manufacturers, the dissolution test of tablets from three manufacturers was carried out with the method described in Chinese Pharmacopoeia （2015 edition）, f2 similar factor was used to analyze the dissolution profile and the Weibull＇s equation was used to fit the dissolution parameters. The dissolution of sertrafine hydrochloride tablets from three manufacturers conformed to the requirements of Pharmacopoeia. But the parameters of homemade preparations were less than imported formulations, and differences in parameters were found. Significant difference was existed in dissolution parameters among the sertraline hydroehloride tablets from three manufacturers, which should be given attention in clinical application.