星点设计—效应面法优化五味子咀嚼片处方

Optimizing the formation of schisandra chinensis chewable tablets by central composite design-reponse surface methodology

目的:以自提五味子浸膏为模型药物,应用星点设计-效应面法优化其咀嚼片处方。方法:采用湿法制粒,以处方中蔗糖、阿司帕坦、磷酸氢钙的用量为主要考察因素,以制剂的硬度、口感为评价指标,根据星点设计原理进行试验,采用多元线性回归和二次多项式方程拟合指标与影响因素之间的数学模型,经效应面法预测最佳处方。结果:采用二次多项式拟合的相关系数优于线性方程,具有较高的可信度。综合效应面优化和评估结果,最终五味子咀嚼片的最佳处方为:蔗糖用量(X_1):41%;阿司帕坦用量(X_2):1.6%;磷酸氢钙用量(X_3):40.6%。结论:通过星点设计-效应面优化法所建立的模型可以用于五味子咀嚼片处方的优化。

Objective： To use the schisandra fruit extract as model drug, and the application of star design-response surface method to optimize its chewable tablet prescription. Methods： The wet legal system grain to the prescription, the amount of sugar, aspartame, calcium hydrogen phosphate were used as the main factors, and the appearance of the preparation, hardness, texture as the evaluation index. According to the principle of star design experiment, multiple linear regression and quadratic polynomial equation fitting index and influencing factors, a mathematical model,was used to predict the best prescription by response surface method. Results： The correlation coefficients of quadratic polynomial fitting were superior to those of the linear equation, with better credibility comprehensive response surface optimization and evaluation results. The best prescription for sucrose： 41%, aspartame： 1.6%,calcium hydrogen phosphate：40.6%. Conclusion： Cental composite design response surface method can be used in fructus schisandrae chewable tablets.