硝苯地平控释片体外溶出一致性评价研究  

Research on the Consistency Evaluation of in Vitro Dissolution of Nifedipine Controlled-release Tablets

作　　者：葛楠 余庆祝 谢秋艳 李桃丽 罗兴洪 GE Nan;YU Qing-zhu;XIE Qiu-yan;LI Tao-li;LUO Xing-hong(Hainan Simcere Pharmaceutical Co.,Ltd.;State Key Laboratory of Translational Medicine and Innovative Drug Development)

机构地区：[1]海南先声药业有限公司 [2]江苏先声药业有限公司转化医学与创新药物国家重点实验室

出　　处：《中国食品药品监管》2023年第4期80-85,共6页China Food & Drug Administration Magazine

基　　金：2021年海南省重点研发计划(ZDYF2021SHFZ043)。

摘　　要：目的:对硝苯地平控释片进行工艺质量一致性评价。方法:选取4种pH不同的溶出介质,采用桨法,分别在不同时间点取样,采用高效液相色谱法(high performance liquid chromatography,HPLC)测定样品溶出度,绘制溶出曲线。计算参比制剂和仿制制剂在相同溶出介质中溶出曲线的相似因子(f2),根据结果判断参比制剂和仿制制剂的溶出曲线的相似程度。结果:在4种pH不同的溶出介质中,参比制剂和仿制制剂溶出曲线的f2均大于50。结论:仿制制剂与参比制剂体外溶出一致。Objective:This study aimed to evaluate the consistency of the process quality for nifedipine controlled-release tablets.Methods:Four dissolution media with different pH values were selected,and the paddle method was used to test the samples at different time points.The dissolution rate of the samples was measured using high performance liquid chromatography(HPLC),and the dissolution curves were plotted.The similarity factor(f2)of the dissolution curves of the generic and reference formulations in the same dissolution medium was calculated to determine the similarity of the dissolution curves of the reference and generic formulations based on the results.Results:In the four dissolution media with different pH values,the f2 values of the dissolution curves of the generic and reference formulations were both greater than 50.Conclusion:The results of the study showed that the in vitro dissolution of the generic formulation was consistent with that of the reference formulation.

关 键 词：硝苯地平控释片 一致性评价 体外溶出 

分 类 号：R927.1[医药卫生—药学]