固体分散体表征手段的研究进展

Advances in Characterization Methods of Solid Dispersion

固体分散体系指药物以分子、无定形、微晶等状态均匀分散在某一固态载体物质中所形成的分散体系。充分研究药物在载体中的状态、药物与载体间的相互作用、固体分散体的结构等问题对固体分散体系统的后续研究和评价非常重要。综述了四大类固体分散体表征手段(溶出度、热分析方法、光谱分析方法及其他常用方法)的原理、方法及近年来的研究进展,展望固体分散体表征技术的研究方向。

Solid dispersion refers to pharmaceutical forms in which active pharmaceutical ingredient （API） is highly dispersed in a biologically inert matrix in the form of molecular, amorphous or crystalline. It is crucial for further studies and evaluations to explore the state of API in carrier, interactions between them as well as the structure of solid dispersion sufficiently. The principle, main content and recent development of several characterization methods, such as dissolution test, thermal analysis, spectrum analysis and other common methods are reviewed in this paper. The future directions of characterization technologies for solid dispersion are also prospected.