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目的:采用星点设计-效应面法优化丹酚酸缓释微丸的处方。方法:以3,4,6 h的累积释放度为考察指标,以HPMC K4M,PVP K30的用量和乙醇浓度为考察因素,采用多元线性模型和二次多项式模型描述考察指标和考察因素之间的数学关系,根据最佳模型绘制等高线图和效应面图,选择最佳处方。按照最佳处方制备丹酚酸微丸,验证处方。结果:二次多项式为拟合的最佳模型,最佳处方微丸3,4,6 h的累积释放度为16.09%,67.56%,78.85%,满足设计要求;实测值与预测值接近,偏差均小于8%。结论:采用星点设计-效应面法很好地优化了丹酚酸缓释微丸的处方,所得最佳处方能够达到实验设计的要求。
OBJECTIVE: To optimize the formulation of salvianolic acid sustained-release pellets by the method of star point design-response surface method. Methods: The cumulative release of 3,4,6 h was taken as the index of investigation. Taking the dosage of HPMC K4M and PVP K30 and the concentration of ethanol as the investigation factors, the multivariate linear model and the quadratic polynomial model were used to describe the relationship between the investigation index and the investigation factors Mathematically, select the best prescription based on the best model to draw contour plots and effect surfaces. In accordance with the best prescription salvianolic acid pellets, verify the prescription. Results: The quadratic polynomial was the best fitting model. The cumulative release of the best prescription pellets at 3, 4 and 6 h was 16.09%, 67.56% and 78.85%, respectively, which met the design requirements. The measured values were close to the predicted values, Less than 8%. CONCLUSIONS: The formulation of salvianolic acid sustained-release pellets is well optimized by the star-point design-response surface method, and the optimal prescription obtained can meet the experimental design requirements.