摘要
缓控释微丸胶囊是常见的缓控释制剂,已逐渐成为缓控释制剂研究开发的热点之一。缓控释微丸胶囊处方工艺研究是否充分,不仅是保证药品质量的基本前提,还是满足临床用药的基础。原辅料控制全面、处方设计合理、生产工艺稳定重现等是处方工艺研究的重点。基于国际人用药品注册技术协调会指导原则和国内外相关文献以及审评中接触到的实际案例,并结合缓控释微丸胶囊制剂特点,围绕缓控释微丸胶囊处方工艺研究关注点,提出处方工艺开发过程中的一般考虑,以期为缓控释微丸制剂的研究和注册申报提供思路和建议。
Extended and controlled release micropill capsules is common sustained-release preparations,and have gradually become one of the hotspots in the research and development of sustained-release preparations.Whether the research on the formulation process of extended and controlled release micropill is sufficient is not only a basic prerequisite for ensuring drug quality,but also a foundation for meeting clinical needs.Comprehensive control of raw materials and auxiliary materials,rational prescription design,and stable and reproducible production processes are the focus of prescription process research.Based on the guiding principles of The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH),relevant domestic and foreign literature,as well as actual cases encountered in reviews,and combined with the characteristics of extended and controlled release micropill capsules,this article focuses on the research focus of extended and controlled release micropill capsules formulation technology,and proposes general considerations in the formulation process development,in order to provide ideas and suggestions for the research and registration application of extended and controlled release micropill capsules.
作者
徐晓宏
陶铭
李飞
魏群
龚青
XU Xiao-hong;TAO Ming;LI Fei;WEI Qun;GONG Qing(Center for Drug Evaluation,NMPA,Beijing 100022,China;School of Pharmacy,Shenyang Pharmaceutical University,Benxi 117004,China)
出处
《现代药物与临床》
CAS
2023年第12期3139-3144,共6页
Drugs & Clinic
关键词
缓控释微丸胶囊
仿制药
处方
工艺
extended and controlled release micropill capsules
generic drug
prescription
process
