缓控释制剂评价方法的研究进展(英文)  

Evaluation methodology on sustained and controlled release preparation

作　　者：朱孟夏[1] 涂颖秋[1] 刘会[1] 黄绳武[1] 

机构地区：[1]浙江中医药大学药学院,杭州310053

出　　处：《中华中医药杂志》2014年第2期537-541,共5页China Journal of Traditional Chinese Medicine and Pharmacy

摘　　要：近年来,缓控释制剂在药学领域取得了很大的发展,建立完整的缓控释制剂质量评价体系是缓控释制剂发展的关键。文章综述了国内外缓控释制剂质量评价的常用方法。体外评价方法主要包括体外释放度等。体内评价方法主要有药物动力学、体内外相关性(IVIVC)、药动-药效学模型(PK-PD)及代谢组学等,通过以上评价方法,建立完整的缓控释制剂评价体系。In recent years, sustained and controlled release preparation has made a great development in pharmacy field. It is extremely crucial for the development of sustained and controlled release preparation to establish a whole evaluation system. This paper summarized some frequently-used methods for quality evaluation of sustained and controlled release preparation. In vitro evaluation methods mainly contain in vitro drug release test etc. In vivo evaluation methods include pharmacokinetics in vitro and in vivo correlation （IVIVC）, pharmacokinetics-pharmacodynamics model （PK-PD） and metabonomics etc. Through those methods above, we would establish a whole evaluation system for sustained and controlled release preparation.

关 键 词：缓控释制剂 体外释放度 药动学 体内外相关性 药动-药效学模型 代谢组学 

分 类 号：R94[医药卫生—药剂学]