目的 利用Minitab软件优化天舒胶囊一步制粒的工艺条件。方法 利用Plackett-Burman设计实验，以颗粒合格率为指标，筛选出天舒胶囊一步制粒的3个主要影响因素：流浸膏-糊精配比、输液频率、雾化压力，并确定非主要影响因素的水平。在此基础上，利用Box-Behnken中心复合原理设计3因素3水平实验，以颗粒合格率、含水量、休止角为指标进行多元线性回归和二项式拟合，并利用Response Optimizer优化实验结果。结果 确定最佳一步制粒工艺条件为按流浸膏-糊精（1.57∶1）的配比将糊精置于流化床内，开启风机并加热，使底料在流化状态下升温至50 ℃，开启喷雾器，以32 Hz的输液频率喷入2%羟丙基甲基纤维素的流浸膏、风机频率30 Hz、进风温度60 ℃、雾化压力0.21 MPa、料液温度50 ℃。结论 用Minitab优化方案制得的颗粒与模型预测值基本一致，可应用于中药一步制粒工艺的优选。

Objective To optimize the one-step pelletization technology of Tianshu Capsule by Minitab software. Methods Using the qualified rates of particles as the evaluation indexes, three significant impact factors (fluid extract-dextrin ratio, infusion frequency, and atomization pressure) of one-step pelletization technology were selected and the levels of non-significant factors were identified by the Plackett-Burman experimental design. According to single factor experiments, choosing the qualified rates of particles, moisture, and angle of repose as the evaluation indexes, three levels of the three factors were selected by Box-Behnken of central composite design to establish the multiple linear regression and binomial fitting, and the experimental data were optimized by the response optimizer. Results The best conditions were as follows: fluid extract-dextrin of 1.57∶1 put in fluid-bed and heated by fan; the temperature of the bottom material in the fluidized state was increased to 50 ℃, fluid extract of 2% HPMC was sprayed with frequency of 32 Hz, the frequency of fan was 30 Hz, inlet air temperature was 60 ℃, atomization pressure was 0.21 MPa, and feed temperature was 50 ℃. Conclusion Under the Minitab optimized scheme, the average experimental results are similar to the predicted values, and Minitab software could be used in the optimization of one-step pelletization for Chinese materia medica.

“重大新药创制”科技重大专项“偏头痛治疗药物天舒胶囊大品种技术改造”（2012ZX09201-201-002）