自微乳化递药系统质量评价的研究进展  

Progress of Quality Evaluation of Self-microemulsifying Drug Delivery System

作　　者：张喜凤[1] 马晋隆[1] 史家骏[1] 倪睿[1] 徐驿 

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203

出　　处：《中国医药工业杂志》2016年第5期637-642,647,共7页Chinese Journal of Pharmaceuticals

摘　　要：自微乳化递药系统(SMEDDS)口服后在胃肠道运动的促进下,能快速自发乳化形成粒径均一的微乳。它可增加难溶性药物的溶解度和生物利用度。对于SMEDDS的质量评价也日益受到重视。本文较全面地综述了能反映SMEDDS结构、稳定性和体外释放行为的质量评价项目及方法。此外,简要介绍了SMEDDS与固体分散、吸附、挤出滚圆等技术相结合得到的自微乳固体制剂给药系统(S-SMEDDS)及质量评价。Self-microemulsifying drug delivery system （SMEDDS） can spontaneously emulsify to form microemulsion with uniform particle size in the gastrointestinal environment after oral administration. SMEDDS is an approach to enhance solubility and bioavailability of poorly soluble drugs. Therefore, the quality evaluation of SMEDDS has received more attention. The evaluation items reflecting structure, stability and in vitro release of SMEDDS and their determination methods are reviewed in this paper. In addition, solid self-microemulsifying drug delivery system （S-SMEDDS） prepared with the combination of SMEDDS and solid dispersion, adsorption or extrusion-spheronization as well as the quality evaluation are briefly introduced.

关 键 词：自微乳化递药系统 质量评价 粒径 结构分析 稳定性 体外释放 综述 

分 类 号：R944.9[医药卫生—药剂学]