【摘要】 热熔挤出技术已成为一种制备药物固体分散体的新方法，螺杆转速作为挤出过程中的工艺参数对药物的混合具有重要影响。以吲哚美辛(INM)和聚乙二醇(PEG10000)为原料，设计了挤出机混合段螺杆构型，采用Polyflow进行数值模拟，基于加权平均剪切应力、累积最大剪切应力分布、累计停留时间分布和平均回流系数，分析螺杆转速对INM混合性能的影响。同时，以INM为原料药，采用热熔挤出技术制备了不同螺杆转速下的挤出样品，使用扫描电子显微镜(SEM)和溶出实验对样品进行表征。结果表明，在一定范围内，随着螺杆转速的增大，药物的分散混合和分布混合性能增强，但是，螺杆转速较大会导致药物分布混合性能降低，不利于药物的混合。更多还原

【Abstract】 Hot melt extrusion technology had become a new method for the preparation of drug solid dispersions, and screw speed as a process parameter in the extrusion process has an important influence on the mixing of drugs. For the raw materials of indomethacin(INM) and polyethylene glycol(PEG10000), the screw configuration of the extruder mixing section was designed and numerical simulations were performed by Polyflow to analyze the effect of screw speed on the mixing performance of INM based on the weighted average shear stress, cumulative maximum shear stress distribution, cumulative residence time distribution and average reflux coefficient. The extruded samples were also prepared by hot-melt extrusion technique with INM as API at different screw speeds and characterized using scanning electron microscopy(SEM) and dissolution experiments. The results showed that the dispersive mixing and distributive mixing performance of the drug was enhanced with the increase of screw speed in a certain range, but too large a screw speed led to a decrease in the distributive mixing performance of the drug, which was not conducive to the mixing of the drug.更多还原