Plackett-Burman联用Box-Behnken响应面法优化依那普利非洛地平双层片缓释层处方

发布时间：2019-01-15 09:11

【摘要】：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。
[Abstract]:The formulation of felodipine sustained release layer in enalapril maleate bilayer tablets was optimized by Plackett-Burman and Box-Behnken response surface method. The prescription factors which influence the cumulative release rate of felodipine were screened by Plackett-Burman test design. The significant factors were further optimized by Box-Behnken response surface method, and the best prescription was predicted by quadratic multivariate regression fitting. The results showed that hydroxypropyl methyl cellulose, lactose and polyoxyethylene 40 hydrogenated castor oil had significant effects on the cumulative release rate of felodipine, and the optimal dosage of lactose 55 mg, hydroxypropyl methyl cellulose (HPMC K 4M) was predicted to be 96 mg,. Polyoxyethylene 40 hydrogenated castor oil 1 mg, self-made sample and reference preparation (Lexxel~?) The release curves of felodipine in various media are similar. The method is simple and convenient for prescription optimization and has good predictability. The experimental results meet the requirements.
【作者单位】：广州白云山医药集团股份有限公司白云山制药总厂;
【基金】：国家“重大新药创制”科技专项(2012ZX09202101-011) 广东省2012年第一批重大科技专项计划项目(2012A080204007)
【分类号】：R943

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