适合挤出滚圆的物料性质与微丸成型性预测指标研究探讨

Analysis of the Property of Material in the Extrusion-Spheronization and the Predictive Index

目的探讨适合以挤出滚圆法制备微丸的物料性质以及微丸成型性预测指标的建立。方法综合国内外文献报道,探讨了物料中液体的饱和度和流动性、药物和辅料粉末的溶解性和保水性、处方的流变学性质参数(扭矩、储能模量和耗能模量、可恢复剪切和顺应性)与微丸成型性的相关性。结果各性质和参数对挤出滚圆均有一定的影响,但是都不能够单独的预测处方是否可以制备成合格的微丸,同时各性质和参数之间存在着协同和交互作用。结论建立一个能够预测微丸成型性的量化指标可能需要物料几个性质和参数的综合或者新的影响因素的发现。

OBJECTIVE To discuss the relativity between material properties and pelletization by the process of extrusion-spheronization.METHODS Make a summary of both national and overseas papers about the suitability of the wet mass used to produce pellets by extrusion-spheronization.This paper is to determine the relevance between the property of wet powder masses（such as the fluid saturation and mobility,the solubility and the ability of holding water of drugs and accessories,the rheological properties） and pelletization.RESULTS Although many properties are relative to the process of extrusion-spheronization,none of them can predict producing qualified pellet.CONCLUSION This paper gives consultation to the further research and exploitation of the material fit for the process of extrusion-spheronization.