星点设计——效应面法优化复方制剂SY片的制剂工艺

Optimization of Preparation Technology of Compound SY Tablets by Response Surface Methodology-Star Dot Design

目的采用单因素考察及星点设计——效应面法优化复方制剂SY片的处方。方法采用二因素五水平星点设计,以预胶化淀粉和微晶纤维素的用量为考察因素,崩解时间和硬度为考察指标,分别用线性方程和二项式拟合方程描述崩解时间和硬度指标与影响因素之间的数学关系,根据最佳模型绘制效应面和等高线图,选择最佳处方并进行验证试验。结果二项式方程为Y=18.65-0.86X1-0.8X2-0.08X1X2+0.09X12+0.07X22,表明考察因素和指标之间存在可信的定量关系。经优化后处方中预胶化淀粉和微晶纤维素的用量分别为片重的16、14.8%。结论筛选后的处方工艺验证值与预测值偏差较小,表明该法具有较好的预测性和可靠性。

Objective Using the single-factor investgation and central composite design to optimize the prescription of compound SY pills.Methods Using two-factor and five-level central composite design.Take the amount of pregelatinized starch and microcrystalline cellulose into consideration. Regard the disintegration time and hardness as the indexes, respectively use the linear equation and binomial equation fitting to describe the relationship between the disintegrating time and hardness index as well as influence factors.According to the best model,draw the effect of surface and contour maps. Pick out the best prescription and carry out the experiment. Results Binomial equation for Y = 18.65- 0.86x1- 0.8x2- 0.08x1x2＋0.09x12＋0.07x22. Which means there is a credible quantitative relationship between the factors and indexes. The optimized prescription of pregelatinized starch and microcrystalline cellulose were 16% and 14.8% of the weight of tablets. Conclusion The prescription process between validation value and value deviation is smaller after screening, which shows that the method has a good predictability and reliability.