固体分散体在改善药物溶出度方面的研究进展

Research progress of solid dispersions in improving drug dissolution

固体分散体技术可用于改善难溶性药物的溶出和吸收,本文作者概述了固体分散体的概念、重要性和发展概况以及存在的问题。结合美国橙皮书对已上市的以固体分散体技术制备的药物进行了总结。对应用较多的热熔挤出法和喷雾干燥法及发展较快的超临界流体技术的原理、关键工艺参数及特点加以说明,说明了相应方法制备得到的固体分散体对药物溶出度的影响,并对其他部分方法进行补充。最后,分析了固体分散体老化问题。旨在为研究固体分散体在改善溶出方面的科研工作者提供方向和科研思路。

Solid dispersion technology can be used to improve the dissolution and absorption of poorly soluble drugs.This review summarizes the concept,importance,development and existing problems of solid dispersions.Combined with the American Orange Book,the marketed drugs prepared by solid dispersion technology are summarized.The principles,key process parameters and characteristics of the hot-melt extrusion method and spray drying method,which are widely used,and the fast-growing supercritical fluid technology are explained.The influence of the solid dispersion prepared by the corresponding method on the dissolution rate of the drug is illustrated,and other methods are supplemented.Finally,the aging problem of solid dispersion is analyzed.This review aims to provide direction and scientific research ideas for researchers who conduct research on improving dissolution of solid dispersions.