芪丹消渴胶囊防潮技术的Box-Behnken响应面法优化研究

Optimization of Damp-proof Technology of Qidan Xiaoke Capsule by Central Composite Design-response Surface Method

目的采用Box-Benhnken响应面分析法优化芪丹消渴胶囊防潮工艺。方法在单因素试验基础上,以辅料比(甘露醇:乳糖)、辅药比、乙醇体积分数、干燥温度为自变量,以芪丹消渴胶囊丹酚酸B保留率(%)为因变量,通过对自变量各水平的多元线性回归及二项式拟合,用效应面法选取最佳工艺,并进行预测分析。结果最佳工艺条件包括辅料比(甘露醇︰乳糖)1.6∶1,辅药比1.6∶1,乙醇体积分数75%,干燥温度68℃;在此条件下,成品颗粒丹酚酸B保留率为92.587%,与模型预测值(92.678%)接近。结论筛选出的防潮工艺能满足芪丹消渴胶囊制备需要,且质量可控。

Objective To optimize the damp-proof technology of Qidan Xiaoke capsule by Central Composite Design-response Surface Methodology.Methods Based on single factor tests,the ratio of the excipients(mannitol-lactose),auxiliary-medicine ratio,ethanol volume percentage and drying temperature were selected as independent variables,dependent variable was retention rate of salvianolic acid B in Qidan Xiaoke Capsule.Linear or no-linear mathematic models were used to estimate relationship between independent and dependent variables.Response surface methodology was used to optimize extraction process.Prediction was carried out through comparing observed and predicted values.Results Optimal damp-proof technology was mannitol-lactose 1.6:1,auxiliary-medicine ratio of 1.6:1,75%ethanol and drying temperature at 68℃.Under this condition,the test value of retention rate of salvianolic acid B in Qidan Xiaoke capsule was 92.587%,and the predicted value was 92.678%.Conclusion Optimized damp-proof technology can meet the requirements of Qidan Xiaoke capsule preparations,and the quality can be good controllable.