混悬型滴眼剂仿制药药学研究的相关考虑
Consideration of pharmaceutical study for the generic drugs of ophthalmic suspension
王家强 1魏婷婷 1杨文智1
作者信息
- 1. 国家药品监督管理局药品审评中心,北京 100076
- 折叠
摘要
混悬型滴眼剂系指难溶性固体药物以微粒状态分散于介质中形成的无菌眼用液体制剂.本文从化学药品仿制药混悬型滴眼剂的处方、生产工艺、质量研究、包材和稳定性研究等药学方面问题进行了初步的探讨,汇总了国内外文献中混悬型滴眼剂开发过程中关键研究指标,以助于业界对混悬型滴眼剂仿制药的开发.
Abstract
Ophthalmic suspension is a sterile liquid preparation formed by dispersing insoluble solid drugs in a disper-sion medium.This paper preliminarily discusses the formulation,manufacturing process,quality study,container and stability study of ophthalmic suspension,and summarizes the key study parameters of ophthalmic suspension development process from the domestic and foreign references,in order to help the industry to develop ophthalmic suspension generic drugs.
关键词
混悬型滴眼剂/仿制药/药学研究Key words
Ophthalmic suspension/Generic drugs/Pharmaceutical study引用本文复制引用
出版年
2024
国家科技期刊平台
NSTL
万方数据