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热熔挤出中药物活性组分混合过程数值模拟研究

         

摘要

This paper reported a study on the numerical simulation for the mixing process of acetaminophen as an active pharmaceutical ingredient and poly(ethylene oxide)as a carrier during hot-melt extrusion by a Polyflow software using particle size,mixing index,separation scale and time-average mixing efficiency as characterization parameters.The influences of rotation speed and the gap between discs on the mixing process were investigated.The results indicated that the dispersion mixing and distribution mixing during hot-melt extrusion were enhanced by increasing the rotating speed and decreasing the gap between discs.Meanwhile,the particle sizes of the active pharmaceutical ingredient were obtained as preliminary data for the analysis of its dissolution mecha-nism.%采用Polyflow软件,分别选取粒径尺寸、混合指数、分离尺度和时间平均混合效率4个表征参数,将以聚氧化乙烯(PEO)为载体的对乙酰氨基酚(APAP)在旋转盘式混合器内进行热熔挤出,研究了转速和磨盘间隙对APAP混合过程的影响规律.结果表明,增大动盘转速,减小磨盘间隙,有利于增强热熔挤出技术过程中的分散混合和分布混合;得到的药物活性组分粒径尺寸可作为分析后续药物溶解机理的初始数据.

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