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目的:采用星点设计-效应面法优化流化床侧喷法制备复方垂盆草微丸的制备工艺。方法:以喷液速度(泵速)、转盘转速和滚圆时间为考察因素,以圆整度、休止角、脆碎度、微丸得率及总评归一值(OD)为指标,采用多元线性回归及二次多项式拟合,建立方程式,根据最佳模型描绘效应面,再根据效应面优选纯化工艺参数。结果:二次多项式拟合的相关系数明显优于多元线性回归方程,根据效应面优化的最佳纯化工艺参数为:喷液速度(泵速)为7 r/min、转盘转速250 r/min、滚圆时间10 min,验证试验表明预测值与实测值无显著性差异。结论:星点设计-效应面优化法用于复方垂盆草微丸的流化床侧喷法制备工艺优化,模型预测性良好,实验设计有较高的可靠性,得到的工艺条件稳定。
OBJECTIVE: To prepare the preparation technology of compound Sagittate pellets by the method of star point design and response surface method. Methods: Taking jet speed (pump speed), rotating speed and rounding time as inspection factors, taking roundness, angle of repose, friability, pellet yield and total evaluation value as indexes, Regression and quadratic polynomial fitting, the establishment of equations, according to the best model depicting the effect surface, and then optimize the process parameters based on the effect surface. Results: The correlation coefficient of quadratic polynomial fitting was better than multivariate linear regression equation. According to the optimization of the effect surface, the optimum purification process parameters were as follows: liquid ejection speed (pump speed) 7 r / min, rotating speed 250 r / min, Spheronization time 10 min, validation test showed no significant difference between predicted and measured values. Conclusion: The star-spot design-response surface optimization method was used to optimize the preparation process of compound Sagituba pellets in the fluidized bed side injection method. The model predictability is good, the experimental design has high reliability and the obtained process conditions are stable.