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目的应用星点设计-效应面法对阿魏酸哌嗪脉冲释药片处方进行优化。方法采用薄膜包衣技术制备阿魏酸哌嗪脉冲释药片,以羧甲基淀粉钠用量和包衣层厚度为考察因素,以释药时滞为考察指标,对羧甲基淀粉钠用量和包衣层厚度进行数学方程的拟合,在优选处方区域内对数学方程进行准确性的验证。结果拟合后的二次多项式方程相关系数为0.992 2,在优选区域内任意选取的4个处方经三批样品制备后其预测时滞与实测时滞偏差±3.2%以内。结论通过星点设计-效应面法建立的数学方程具有良好的预测性,可用于阿魏酸哌嗪脉冲释药片处方的优化。
Objective To optimize the formulation of piperazine ferulic acid pulse tablets by using the apical design-effect surface method. Methods The film-coating technique was used to prepare the piperazine ferulic acid pulsed release tablets. Taking the dosage of sodium carboxymethyl starch and the thickness of coating layer as the investigation factors, the delay of drug release was taken as the investigation index. The dosage of sodium carboxymethyl starch and the package The thickness of the layer was fitted to a mathematical equation to verify the accuracy of the mathematical equations within the preferred prescription area. Results The quadratic polynomial equation after fitting showed a correlation coefficient of 0.992 2. The predicted delay and the measured delay deviation were within ± 3.2% of the 4 randomly selected 4 prescriptions in the preferred region after three batches of samples were prepared. Conclusion The mathematical equation established by the apical-point design-response surface method has good predictability and can be used to optimize the formulation of the piperazine ferulic acid pulsed release tablets.