氯雷他定片剂一致性评价研究方法-药学进展.pdfVIP

PROGRESS IN PHARMACEUTICAL SCIENCES 2017,41 3 :179-185 ( ) 179 氯雷他定片剂一致性评价研究方法 陆依华 1,2 ，田媛 1,2 ，张尊建 1,2 * (1. 中国药科大学药物质量与安全预警教育部重点实验室，江苏 南京 210009；2. 中国药科大学药物一致性评价重点实验室，江苏 南京 210009) [ 摘要 ] 为改善我国部分仿制药质量与国际先进水平还存在一定差距的现状，《国家药品安全“十二五”规划》中明确提出了开展仿制药一 致性评价，全面提高仿制药质量的任务。氯雷他定片作为抗过敏药物的主要品种之一，需在 2018 年底前完成一致性评价。基于现有质量和 疗效一致性评价指导原则与相关研究报道，针对氯雷他定原料药的晶型研究、原辅料杂质的比较研究、片剂溶出曲线的比较方法以及生物 等效性试验研究等进行了总结和概括，并对有待解决的共性问题进行了讨论。 [ 关键词 ] 氯雷他定片；仿制药；一致性评价；溶出曲线；生物等效性 [ 中图分类号 ] R94 [ 文献标志码 ] A [ 文章编号 ] 1001-5094（2017）03-0179-07 Investigations on Consistency Evaluation for Loratadine Tablets LU Yihua1,2, TIAN Yuan1,2, ZHANG Zunjian1,2 (1. Key Laboratory of Drug Quality Control and Pharmacovigilance, China Pharmaceutical University, Ministry of Education, Nanjing 210009, China; 2. Key Laboratory of Drug Consistency Evaluation, China Pharmaceutical University, Nanjing 210009, China) [Abstract] In order to reduce the quality gap between some generic drugs in China and the international advanced level, “National Drug Safety ‘Twelfth Five-Year Plan’” clearly put forward the task of conducting consistency evaluation and improving the quality of generic drugs. Loratadine tablet is one of the major anti-allergic drugs, and its consistency evaluation needs to be completed before 2018. Based on the existing guidelines and research reports on quality and efficacy consistency evaluation, this review summarized the study on polymorphism of loratadine bulk drug, comparative study of impurities in API and excipients, methods to compare dissolution curves of tablets and the study of bioequivalence test. Also, some common problems to be solved were discussed. [Key words] loratadine tablet; generi