比卡鲁胺片仿制药和原研药的质量比对  

Quality Consistency Evaluation of the Original and Generic Bicalutamide Tablets

作　　者：江文明[1] 刘茜[1] 金薇[1] 宋冬梅[1] 杨永健[1] JIANG Wenming;LIU Qian;JIN Wei;SONG Dongmei;YANG Yongjian(Shanghai Institute of Food and Drug Control,Shanghai 201203)

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国医药工业杂志》2018年第10期1421-1427,共7页Chinese Journal of Pharmaceuticals

摘　　要：比较了比卡鲁胺片原研药和仿制药的有关物质、含量、含量均匀度和溶出曲线,以评价仿制药与原研药的一致性。采用HPLC法测定有关物质、含量均匀度和含量。采用桨法,转速50 r/min,以均含0.5%十二烷基硫酸钠(SDS)的盐酸溶液(pH 1.2)、乙酸盐缓冲液(pH 4.0)、磷酸盐缓冲液(pH 6.8)及0.5%SDS溶液为溶出介质,采用UPLC法在270 nm波长处测定介质中的药物浓度,并绘制出溶出曲线,采用相似因子(f2)进行比较分析。结果显示,仿制药的有关物质与原研药杂质谱不完全相同,且其杂质含量高于原研药;仿制药批次之间含量均匀度变化较大;仿制药在不同溶出介质中的溶出曲线与原研药存在一定程度的差异。The aim of the study was to evaluate the consistency of impurity, content, content uniformity and dissolution curves between the original and generic bicalutamide tablets. Impurity, content and content uniformity were measured using HPLC method. Drugs were dissolved using paddle stirring method with paddle speed of 50 r/min. The dissolution medium were pH 1.2 hydrochloric acid, pH 4.0 acetate buffer, pH 6.8 phosphate buffer and water, all of which containing 0.5% sodium dodecyl sulfate （SDS）. UPLC method was used to determine the drug concentration at the wavelength of 270 nm. The dissolution curves were drawn and the similarity factor （f2） was used for the consistency analysis. The results showed that the impurity of the generic drugs were not exactly the same as that of the original drugs. The content of the impurity in the generic drugs was higher than that in the original drugs. The content uniformity varied greatly among different batches of generic drugs. The dissolution curves of the generic drug in various kinds of dissolution medium were different from those of the original one. In conclusion, in vitro dissolution of the generic and original bicalutamide tablets evaluated in our study are not consistent.

关 键 词：比卡鲁胺片 有关物质 溶出曲线 含量均匀度 一致性评价 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]