FDA对眼用制剂的质量研究要求及启示  

FDA's requirements for quality research of ophthalmic preparations and its enlightenment

作　　者：王慧明 徐萍蔚 萧惠来 WANG Huiming;XU Pingwei;XIAO Huilai(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《药物评价研究》2024年第5期951-958,共8页Drug Evaluation Research

摘　　要：美国食品药品管理局(FDA)于2023年12月28日发布了题为“局部外用眼科药品的质量考虑”的指导原则草案,对2023年10月发布的同名指导原则草案进行了修订。该指导原则草案讨论了用于眼内和眼周局部给药的眼用产品,包括凝胶、软膏、乳膏和液体制剂等剂型的眼用制剂的一些质量考虑,涵盖质量研究中微生物学、可见颗粒物、可提取物和可浸出物、杂质和降解产物、稳定性研究5个方面,并对容器密封系统(CCS)设计等提出了相关建议。详细介绍FDA该指导原则草案主要内容,期望对该类药物的研发和质量评价有所启示。On December 28,2023,the U.S.Food and Drug Administration(FDA)issued"Quality Considerations for Topical Ophthalmic Drug Products Draft Guidance for Industry"The guidance revised the draft guidance of the same name released in October 2023.Considerations for some quality studies of ophthalmic products intended for topical administration into and around the eye,including gels,ointments,creams,and liquid formulations such as solutions,suspensions,and emulsions,are discussed,covering five aspects of quality research:Microbiology,visible particulate matter,extractables and leachables,impurities and degradation products,and stability research,and elaborates on relevant suggestions for design of container closure system(CCS),etc.This article introduces the main contents of the FDA's guidance in detail,hoping to shed some light on the research and development of this type of drug.

关 键 词：美国食品药品管理局(FDA) 眼用制剂 质量评价 微生物学 可见颗粒物 杂质和降解产物 容器密封系统(CCS) 

分 类 号：R951[医药卫生—药学]