丹桃颗粒成型工艺优选

Optimization of Molding Process for Dantao Granules

目的:优选丹桃颗粒的成型工艺。方法:以可溶性淀粉和糊精用量比、辅料用量和乙醇体积分数为自变量,合格颗粒收率、溶化性及临界相对湿度为因变量,采用星点设计-效应面法和总评归一值法优选丹桃颗粒的成型工艺。结果:最佳成型工艺条件为辅料-浸膏粉混合物用量比2∶1,可溶性淀粉-糊精(1∶1),润湿剂为75%乙醇;制备的颗粒剂合格收率约85%,溶化时间<1 min,临界相对湿度约58%。结论:优选的成型工艺稳定可靠,制备的丹桃颗粒具有合格率高、溶化性好、抗吸湿性强的特征,为丹桃颗粒的制备及生产环境控制提供实验依据。

Objective： To optimize forming process of Dantao granules. Method： With ratio of soluble starch-dextrin,excipients consumption and ethanol concentration as independent variables,yield of qualified granules,dissolubility and critical relative humidity as dependent variables,forming process of Dantao granules was optimized by central composite design-response surface methodology and overall desirability method. Result： Optimal molding technology conditions were as follows：quality ratio of excipients-extract powder （2：1）,proportion between starch-dextrin （1：1）,with 75% ethanol as wetting agent;yield of qualified granules was about 85%,melting time was less than 1 min,critical relative humidity was about 58%. Conclusion： Optimized molding process was stable and reliable with high qualified rate,good dissolubility and strong anti-hygroscopicity,this research could provide basis for preparation and production environmental control of Dantao granules.