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目的应用星点设计-效应面法优化盐酸青藤碱结肠定位片的处方。方法以肠溶层包衣增质量分数、尤特奇S100和L100质量比为考察因素,以药物在第6、8、12 h累积释放度的综合评分值Y作为评价指标,运用Statistica 6.0软件对实验数据进行多元线性拟合和二项式拟合,对比拟合结果得出最佳数学模型,绘制三维效应面图和等高线图,优选最佳处方并验证。结果二项式拟合方程相关系数(r=0.994 7)优于多元线性拟合方程的相关系数(r=0.168 5),所以最终选择二项式拟合为最佳数学模型,优选的最佳处方为肠溶层包衣增质量分数为4.5%,S100和L100的质量比为3∶1,对优选处方进行验证结果均符合结肠定位释药要求。结论星点设计-效应面法简单可靠,所建立的数学模型具有良好的预测性,可以用来优化盐酸青藤碱结肠定位片的处方。
Objective To optimize the prescription of Sinomenine Hydrochloride Colon Positioning Tablet by the method of Asterisk Design - Response Surface Methodology. Methods The mass fraction of enteric coating and the mass ratio of Eudragit S100 and L100 were taken as the investigation factors. The comprehensive score Y of the cumulative release of drug at the 6th, 8th and 12th hour was used as the evaluation index. Using Statistica 6.0 software The experimental data were subjected to multiple linear fitting and binomial fitting, and the best mathematical model was obtained by comparing the fitting results. The three-dimensional effect surface maps and contour maps were drawn, and the optimal prescription was optimized and verified. Results The correlation coefficient (r = 0.994 7) of the binomial fitting equation was superior to that of the multivariate linear fitting equation (r = 0.168 5), so the final binomial fit was selected as the best mathematical model and the optimal one Prescription for the enteric layer coating mass fraction of 4.5%, S100 and L100 mass ratio of 3: 1, the preferred prescription validation results are in line with the colon-specific release requirements. Conclusions The design of star-point-response surface method is simple and reliable. The mathematical model established has good predictability and can be used to optimize the prescription of Sinomenine Hydrochloride colon positioning tablets.