清肝益脾胶囊的成型工艺优化

Optimization of the forming process of Qinggan Yipi Capsules

目的优化清肝益脾胶囊的成型工艺。方法用单因素实验筛选辅料种类、辅料比例、润湿剂种类及用量;以药物辅料比、润湿剂用量、干燥时间和干燥温度为影响因素,以吸湿率、成型率和休止角为评价指标,应用正交实验优选颗粒成型工艺。结果辅料最优条件为乳糖与可溶性淀粉用量比为2∶1,药物辅料比为4∶1,润湿剂为体积分数为85%的乙醇,比例为60%,过20目筛,50℃干燥2 h,平均休止角为29.60°,颗粒平均成型率为78.65%,临界相对湿度为68.74%,平均吸湿率为6.83%。结论该成型工艺合理,可为清肝益脾胶囊的工业生产提供依据。

Objective To optimize the molding process of Qinggan Yipi Capsules.Methods The type of excipients,the proportion of excipients,the type and dosage of wetting agent were screened by single factor test.Taking the ratio of medicine to excipients,the amount of wetting agent,drying time and drying temperature as the influencing factors,and the hygroscopic rate,molding rate and angle of repose as the evaluation indexes,an orthogonal experiment test was used to optimize the particle forming process.Results The optimal conditions were as follows:the ratio of lactose to soluble starch 2∶1 and the ratio of drug to excipients 4∶1,the wetting agent ethanol with 85% volume fraction,ratio 60%,20 mesh sieve,50℃ drying for 2 hours,the average angle of repose 29.60°,the average particle forming rate 78.65%,the critical relative humidity 68.74%,and the average moisture absorption rate 6.83%.Conclusion The forming process is reasonable and can provide basis for the industrial production of Qinggan Yipi Capsules.