基于多指标综合评分法优化丹骨颗粒成型工艺

Multi-index comprehensive evaluation to optimize the molding process of Dangu granules

目的采用多指标综合评价法结合三个试验设计优化丹骨颗粒成型工艺。方法以颗粒成型率、化学成分保留率和物理属性指标综合加权评分后作为评价指标,使用D-optimal试验筛选混合辅料配比,Plackett-Burman试验筛选对成型结果有重要影响工艺步骤,Box-Behnken试验对筛选出的工艺步骤进行参数优化。结果混合辅料最佳配比为乳糖-糊精-可溶性淀粉(0.200∶0.476∶0.324),对成型工艺具有重要影响的工艺步骤及其最优参数为药辅比(1∶1.73)、润湿剂用量(40%)和干燥温度(60℃)。结论使用多指标综合评分法优化后的成型工艺制成的丹骨颗粒成型率高,化学指标性成分保留率高,并且物理属性均一稳定、安全可控。

Objective To optimize the molding process of Dangu granules by multi-index evaluation and design of experiment method.Methods The comprehensive weighted scores of particle molding rate,chemical composition retention rate and physical properties were used as the evaluation index.The D-optimal design was used to screen the mixing ratio of auxiliary materials.The Plackett-Burman design was used to select the process steps which influenced the molding results.The Box-Behnken design was used to optimize the process parameters.Results The best mixing ratio of auxiliary materials was lactose-dextrin-soluble starch(0.200∶0.476∶0.324).The drug-auxiliary ratio at 1∶1.73 influenced the process steps most,the amount of wetting agent at 40%and the drying temperature at 60℃.Conclusion Dangu granules by the optimized molding process with multi-index comprehensive scoring method have high molding rate,high retention of chemical index components,with uniform and stable physical properties,safe and controllable.