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目的:考察挤出-滚圆的工艺参数对番泻苷微丸性质的影响,优化番泻苷微丸的制备工艺。方法:采用挤出-滚圆法制备微丸,以挤出速度、滚圆速度、滚圆时间为自变量,得丸率、圆整度、归一化总值为因变量,采用3因素3水平的Box-Behnken设计进行试验,借助Minitab 14拟合评价指标对自变量的效应面,分析工艺参数对微丸性质的影响,优化微丸制备工艺,并对优化工艺进行验证。结果:最优工艺参数:挤出速度为17 r·min-1,滚圆速度为740 r·min-1,滚圆时间为3 min。该工艺制备的微丸得丸率(84.71±2.38)%,水平面临界角(9.38±0.60)°,总分(0.90±0.04),实测值与预测值(0.86)无显著差异。结论:采用Box-Be-hnken设计-效应面法能够快速得到番泻苷微丸制备工艺的优化模型,实现了工艺的优化。
OBJECTIVE: To investigate the effect of extrusion-spheronization parameters on the properties of sennoside pellets and to optimize the preparation of sennoside pellets. Methods: The pellets were prepared by extrusion-spheronization method. The extrusion rate, spheronization rate and spheronization time were taken as independent variables. The pellet yield, roundness and normalized value were taken as dependent variables. The three-level and three- -Behnken design experiments, with Minitab 14 fitting evaluation indicators on the effect of independent variables, the analysis of process parameters on the nature of the pellets, pellets to optimize the preparation process, and to verify the optimization process. Results: The optimum process parameters were extrusion speed of 17 r · min-1, rolling speed of 740 r · min-1 and spheronization time of 3 min. The results showed that the pellets obtained in this process had a mean of 84.71 ± 2.38%, a critical angle of 9.38 ± 0.60 ° and a total score of 0.90 ± 0.04. There was no significant difference between the measured value and the predicted value (0.86). Conclusion: Box-Be-hnken design-response surface method can be used to rapidly obtain the optimized model of the preparation process of Sennoside Pellets and optimize the process.