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目的:通过星点设计-效应面法优化四逆散双层渗透泵片处方。方法:以含药层N750用量和NaC l用量、包衣液中PEG 4000用量和包衣增重为考察因素,以药物释放曲线的相关系数和12 h的累积释放量为考察指标,分别用多元线性模型、二次多项式模型和三次多项式模型描述考察指标和任意2个考察因素之间的关系,并绘制了三次多项式模型的效应面和等高线图,通过重叠区域确定优化处方,并通过实验值与预测值比较进行验证。结果:三次多项式为拟合的最佳模型,优化处方考察指标的实验值与预测值非常接近。12 h的累积释放量为97.86%,释放曲线相关系数为0.995 6。结论:采用星点设计-效应面法得到了基于三次多项式模型的四逆散渗透泵片处方优化的模型,实现了该渗透泵片的处方优化。
OBJECTIVE: To optimize the prescription of Sini Powder double osmotic pump by apices design-response surface method. Methods: The content of drug-containing layer N750 and the amount of NaC l, the amount of PEG 4000 coating coating weight and coating weight as a factor to investigate the correlation coefficient of drug release curve and cumulative release 12 h as indicators, respectively, with multiple Linear model, quadratic polynomial model and cubic polynomial model to describe the relationship between the investigation index and any two factors, and draw the cubic polynomial effect surface and contour map, through the overlap region to determine the optimal prescription and through the experiment The value is compared with the predicted value. Results: The cubic polynomial was the best model for fitting. The experimental value of the optimized prescription inspection index was in good agreement with the predicted value. The cumulative release at 12 h was 97.86%, and the correlation coefficient of release curve was 0.995 6. CONCLUSIONS: The optimized formulation of Siniperon osmotic pump based on cubic polynomial model was obtained by the method of star point design-response surface method, and the prescription optimization of the osmotic pump was achieved.