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通过Plackett-Burman联用Box-Behnken响应面法优化马来酸依那普利非洛地平双层片中非洛地平缓释层的处方。采用Plackett-Burman试验设计筛选对非洛地平累积释放率影响显著的处方因素,再用Box-Behnken响应面法对显著因素进一步优化,并进行二次多元回归拟合,预测最佳处方。结果表明羟丙甲纤维素、乳糖和聚氧乙烯40氢化蓖麻油对非洛地平的累积释放率影响显著,预测最优处方中乳糖用量为55 mg,羟丙甲纤维素(HPMC K4M)用量为96 mg,聚氧乙烯40氢化蓖麻油用量为1 mg,自制样品与参比制剂(Lexxel~?)中的非洛地平在多种介质中的释放曲线相似。该方法用于处方优化操作简便,预测性良好,试验结果符合要求。
Formulation of sustained-release capsules of felodipine maleate enalapril felodipine based on Box-Behnken response surface methodology by Plackett-Burman. Plackett-Burman test design was used to screen prescription factors that have significant effect on the cumulative release rate of felodipine, and then the significant factors were further optimized by Box-Behnken response surface methodology. Second-order multiple regression fitting was performed to predict the optimal prescription. The results showed that hypromellose, lactose and polyoxyethylene 40 hydrogenated castor oil had significant effects on the cumulative release rate of felodipine. The optimum dosage of lactose was 55 mg and the dosage of hypromellose (HPMC K4M) was 96 mg and the dosage of polyoxyethylene 40 hydrogenated castor oil was 1 mg. Similar to the release profiles of felodipine in home-made and reference formulations (Lexxel ~?) In various media. The method for prescription optimization is simple, predictable and the test results meet the requirements.