摘要
近年来,脂质体产品陆续上市。然而,各国药典中并未收录脂质体药物体外释放度检测的标准化方法,给脂质体药物的开发和监管带来了极大的挑战。体外释放度是评估药物制剂产品质量的重要技术指标,在产品开发、质量研究以及产品放行等方面具有关键作用。文章介绍了国内外报道的脂质体产品体外释放方法及检测装置,并阐述了已上市产品体外释放方法的选择依据,期望促进和完善脂质体体外释放度检测方法的发展,为脂质体产品的研发和监管提供更科学、准确的数据支持。
In recent years,liposome products have been successively launched.However,standardized testing methods for in vitro release of liposomal products have not been incorporated in various pharmacopoeias,which poses great challenges for the development and regulation of liposomal products.In vitro release is an important technical indicator for evaluating the quality of pharmaceutical preparations,and plays an important role in product development,quality research,and product release.This review introduces the in vitro release methods and detection apparatuses of liposomal products reported both domestically and internationally,and elaborates on the selection basis of in vitro release methods suitable for approval products.It is hoped that this review will promote and improve the development of in vitro release methods for liposomes,and provide more scientific and accurate data support for the research and regulation of liposome products.
作者
高冬旭
赵源
陆伟根
何军
胡清源
GAO Dongxu;ZHAO Yuan;LU Weigen;HE Jun;HU Qingyuan(National Advanced Medical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203)
出处
《中国医药工业杂志》
EI
CAS
CSCD
2024年第4期445-455,共11页
Chinese Journal of Pharmaceuticals
关键词
脂质体
体外释放
评价方法
质量评价
liposome
in vitro release
evaluation method
quality control
