中文摘要：

目的研究高速搅拌制粒过程参数与混合粉体成粒性的相关性。方法模型药物穿心莲提取物分别与淀粉或微晶纤维素等比例混合制备混合粉体，采用部分因子筛选实验设计设置过程参数，高速搅拌制备颗粒。以颗粒收率、团块和细粉比例为指标评价成粒行为，采用逐步回归法分析过程参数对粉体成粒行为的影响，并采用标准最小二乘法建立成粒性与过程参数数学模型，预测颗粒收率。结果过程参数对粉体成粒性具有较大的影响，且对淀粉和微晶纤维素混合粉体表现出不一致的作用。模型预测颗粒收率为（66．7±3．7）％，实际测定淀粉和微晶纤维素混合粉体颗粒收率分别为68．9％，66．1％。结论所建立的模型能够较好地预测颗粒收率，为优化高速搅拌制粒过程参数、提高颗粒收率提供了研究基础。

英文摘要：

OBJECTIVE To investigate the relationship between the process parameters and granulation behavior during high shear granulation process. METHODS Andrographis extract was utilized as a model drug and mixed with microcrystalline cellulose （ MCC ） or soluble starch at the ratio of 1 ： 1 by weigh, respectively. The process parameters were selected according to fractional factori- al experiment. The granules were prepared by using high shear granulation. The aggregation behavior was evaluated by granule yield and ratio of lumps and fine powder. The effect of process parameters on granulation behavior was analyzed through stepwise regression. Standard least squares regression analysis was used to establish the mathematical model of granule yield. RESULTS The process pa- rameters had different effects on the granulation behaviors of MCC and starch mixtures. The granule yield predicted by the fitting model was （66. 66 ± 3.7 ）% , and the measured values for MCC and starch mixture were 68.9% and 66. 1% , respectively. CONCULS1ON The established mathematical model is useful in predicting the performance of materials duing high shear granulation process. Under- standing the impact of process parameters on granulation behavior provides the basis of modulating granulation parameters in order to optimize product performance and improve the yield.