星点设计-效应面法优选参麦胶囊成型工艺

Optimization of Molding Process of Shenmai Capsule with Central Composite Design-Response Surface Methodology

目的优选参麦胶囊的成型工艺。方法以吸湿性、成型性及流动性为指标,通过单因素试验确定辅料及辅料用量,采用星点设计-效应面法优选乙醇浓度、乙醇用量等成型工艺参数。结果确定最佳成型工艺为:选用微晶纤维素为辅料,用量为40%;乙醇浓度为70%,用量为20%(g/ml),总评"归一值"(overall desirability,OD)平均值0.600 5,与模型方程理论预测值(0.627 5)的偏差-4.30%。制备的颗粒合格率91.67%,临界相对湿度约为68%。结论采用星点设计-效应面法优选得到的参麦胶囊成型工艺稳定可行,制备的颗粒具有合格率高、流动性好、堆密度高、抗吸湿性强的特征,为该制剂之后的大生产提供参考。

Objective To optimize the molding process of Shenmai capsules.Methods The hygroscopicity,formability and fluidity are used as indicators to determine the amount of excipients and auxiliary materials by single factor test.The star point design-effect surface method is used to optimize the molding process parameters such as ethanol concentration and ethanol dosage.Results Determine the best molding process:use microcrystalline cellulose as auxiliary material,the amount of auxiliary materials is 40%,the concentration of ethanol is 70%,and the amount of ethanol is 20%(g/ml).The(overall desirability,OD)average value is 0.600 5,which is-4.30%from the theoretical prediction of the model equation(0.627 5).The prepared pellets have a pass rate of 91.67%and a critical relative humidity of about 69%.Conclusion The preparation process of shenmai capsule which is preferably obtained by star point design-effect surface method is stable and feasible.The prepared granules have the characteristics of high yield,good fluidity,high bulk density and strong hygroscopicity,and provide reference for large production after the preparation.