质子泵抑制剂类肠溶仿制制剂开发中药学研究的一般考虑  

General considerations on the pharmaceutical research in the development of enteric coated generic formulations for proton pump inhibitors

作　　者：张保梅 陈会 陆骁骏 ZHANG Bao-mei;CHEN Hui;LU Xiao-jun(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国新药杂志》2024年第19期2028-2032,共5页Chinese Journal of New Drugs

摘　　要：目前有越来越多的药物制备成肠溶制剂,笔者根据以往审评经验,同时参考调研文献,主要以质子泵抑制剂类肠溶制剂为切入点,从肠溶制剂的处方工艺、质量研究、稳定性等方面,提出了药学研究的一般考虑,重点需关注调试制剂的剂量倾泻研究、溶出曲线相似性研究和涉及鼻胃管给药时的体外对比研究等,以期对该类仿制药物的研发和注册申报提供参考。At present,enteric coated preparations are increasingly used for drugs.Based on the past evaluation experience and reference to research literature,this article mainly focuses on the formulation process,quality research,stability,and other aspects of enteric coated preparations for proton pump inhibitors.We also propose general considerations for pharmaceutical research,and pay attention to the study of dose-elution,similarity of dissolution curves and in vitro comparative studies involving nasogastric tube administration.Based on the above discussions,we hope to provide a reference for the development and registration application of such generic drugs.

关 键 词：肠溶制剂 拉唑类 处方工艺 质量研究 稳定性 

分 类 号：R944[医药卫生—药剂学]