过程性因素对固体分散体稳定性的影响

    Effect of Process Factors on the Stability of Solid Dispersions

    • 摘要: 固体分散体是改善难溶性药物溶解度、溶出行为和生物利用度的有效途径,但固体分散体稳定性差已成为制约以固体分散技术为基础的给药系统市场化的瓶颈问题。本文探讨制备方法、制剂工艺、储存条件等过程性因素对固体分散体的重结晶、药物成分含量、溶出、外观等稳定性的影响,为固体分散体研究与开发提供指导。

       

      Abstract: Solid dispersion(SD) is an effective way to improve the solubility, dissolution behavior and bioavailability of insoluble drugs. However, the poor stability of SD has become the bottleneck problem restricting the marketization of drug delivery system based on solid dispersion technology. The effects of process factors such as preparation method, preparation technology and storage conditions on the stability of SD recrystallization, drug composition content, dissolution and appearance are discussed, which provides guidance for SD research and development.

       

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