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目的通过星点设计-效应面法优化替硝唑结肠靶向生物黏附片处方。方法以海藻酸钠用量(X1)、羟丙基甲基纤维素用量(X2)及包衣增重(X3)为考察因素,以3和12h的累积释放度为考察指标,分别用多元线性模型、二次多项式模型描述考察指标和3个考察因素之间的数学关系,根据模型绘制效应面和等高线图,通过重叠等高线图确定优化处方,最后进行验证。结果根据二次多项式模型,发现3个考察因素和2个考察指标之间存在可信的定量关系;优化处方各设定指标的预测值和测定值非常接近;二次多项式模型比多元线性模型置信度高。结论采用星点设计-效应面法,得到了基于二次多项式模型的替硝唑结肠靶向生物黏附片处方优化模型,实现了该结肠靶向生物黏附片的处方优化。
Objective To optimize the formulation of tinidazole colon targeted bioadhesive tablets by the method of apical design - response surface method. Methods Taking the dosage of sodium alginate (X1), the amount of hydroxypropyl methylcellulose (X2) and the weight gain of coating (X3) as the investigation factors, the cumulative release rates of 3 and 12h were taken as the indexes of investigation. The second-order polynomial model describes the mathematical relationship between the investigation index and the three factors. The response surface and the contour map are drawn according to the model. The optimized formulation is determined by overlapping contour maps and finally verified. Results According to the quadratic polynomial model, it was found that there was a credible quantitative relationship between the three investigation factors and the two investigation indexes. The predicted value and the measured value of each set index of the optimized prescription were very close to each other. The quadratic polynomial model was more confident than the multivariate linear model High degree. Conclusions The prescription optimization model of tinidazole colon targeting bioadhesive patch based on quadratic polynomial model was obtained by the method of star point design - response surface method, and the formulation optimization of the colon targeting bioadhesive patch was achieved.