响应面法优化救心颗粒成型工艺研究

Optimization of the molding process of Jiuxin granules by response surface methodology

通过响应面法优选救心颗粒成型工艺。以喷干粉与辅料用量配比、辅料混合比例及乙醇体积分数为考察因素,以颗粒成型率、吸湿率的总评归一值为评价指标,采用三因素五水平中心组合设计-响应面法优化救心颗粒成型工艺。结果显示,救心颗粒的最佳成型工艺为喷干粉与辅料质量比1.00∶1.30,辅料混合质量比1∶1,乙醇体积分数80%;验证试验表明吸湿率与成型率总评归一值为0.796,与预测值0.817相近,且颗粒的水分、溶化性、堆密度、休止角等检测指标均符合规定。优化后的工艺稳定、可靠,所制得的颗粒外观粒度及流动性均较好,吸湿性小,可用于救心颗粒的规模化生产。

The objective was to optimize the molding process of Jiuxin granules. The proportion of spray-dried powder and excipients, the mixing ratio of excipients and the volume fraction of ethanol were used as the factors to be investigated, the normalized value of the overall evaluation of particle forming rate and moisture absorption rate was used as the evaluation index, and the center combination design of 3 factors and 5 levels-response surface was adopted. The optimal molding process of Jiuxin granules was spray-dried powder and auxiliary materials ratio of 1.00∶1.30, auxiliary materials mixed ratio of 1∶1, and ethanol volume fraction of 80%. The predicted value was close to 0.817, and the physical pro-perties of the particles were stable and in compliance with the regulations. The optimized process is stable and reliable, and the obtained granules have good appearance, particle size and fluidity, and low hygroscopicity, which can be used for the production of Jiuxin granules.