仿制药盐酸达拉他韦片与原研药DAKLINZA^(®)体外溶出一致性评价研究  

In vitro dissolution conformity evaluation of generic Daclatasvir Hydrochloride Tablets with the investigational drug DAKLINZA^(®)

作　　者：鲍美玲 孙春艳[2,3] 程刚[1] BAO Meiing;SUN Chunyan;CHENG Gang(School of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016,China;Yangtze River Pharmaceutical Group Co.Ltd.,Taizhou 225300,China;State Key Lab of Advanced Pharmaceutical Formulation with High Technology,Taizhou 225300,China)

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016 [2]扬子江药业集团有限公司,江苏泰州225300 [3]药物制剂新技术国家重点实验室,江苏泰州225300

出　　处：《中国药剂学杂志（网络版）》2024年第2期51-61,共11页Chinese Journal of Pharmaceutics：Online Edition

摘　　要：目的建立盐酸达拉他韦片溶出方法,考察自制制剂与原研药DAKLINZA®在多种溶出介质中的溶出相似性,为该品种的仿制药研发提供参考。方法采用桨法,分别以pH1.0盐酸、pH4.5醋酸盐、pH6.8磷酸盐缓冲液(含0.15%苄泽35)为溶出介质,采用高效液相色谱法检测盐酸达拉他韦片,应用系统的方法学,对自制制剂与参比制剂溶出曲线相似性进行验证。结果所建立的溶出方法线性、准确度良好,自制制剂与参比制剂在pH1.0盐酸介质中15min时,溶出度均大于85%;在pH4.5醋酸盐、pH6.8磷酸盐缓冲液(含0.15%苄泽35)介质中,溶出曲线f2值均大于50,说明二者溶出具有相似性。结论自制制剂与参比制剂在多种溶出介质中溶出相似,说明二者体外溶出一致。Objective To establish the dissolution of Daclatasvir Hydrochloride Tablets and investigate the similarity between the dissolution of the self-made formulation and the investigational drug DAKLINZA®in various dissolution media,so as to provide a reference for the development of the generic drug.Method The similarity of the dissolution between the self-made formulation and the reference formulation was determined by paddle method,using pH 1.0,pH 4.5 acetate and pH 6.8 phosphate buffer(containing 0.15%brij 35)as the dissolution media.And the high-performance liquid chromatography was employed to establish the dissolution of Daclatasvir Hydrochloride Tablets,and systematic method validation was performed.Results The linearity and accuracy of the established dissolution were good.The dissolution percentages of both the self-made formulation and the reference formulation were greater than 85%at 15 min in pH 1.0 hydrochloric acid media,and the f2 values of the dissolution were greater than 50 in pH 4.5 acetate and pH 6.8 phosphate buffer(containing 0.15%brij 35)media,indicating the similarity of the dissolution between them.Conclusion The dissolution performances of the self-made formulation and the reference formulation are similar in a variety of dissolution media,indicating that they are consistent in vitro.

关 键 词：盐酸达拉他韦片 溶出 一致性评价研究 f2相似因子法 

分 类 号：R94[医药卫生—药剂学]