星点设计-效应面法优化双嘧达莫包合物制备工艺

发布时间：2018-05-14 21:31

  本文选题：双嘧达莫(DIP) + β-环糊精(β-CD)　； 参考：《中国医院药学杂志》2015年02期

【摘要】：目的:星点设计-效应面法优化双嘧达莫(DIP)-β-环糊精(β-CD)包合物制备工艺。方法:以饱和水溶液法制备DIP-β-CD包合物,采用星点设计优化制备工艺,以β-CD/DIP质量比、包合时间和包合温度为自变量,包合率为因变量,分别进行多元线性回归和二项式方程拟合,优选最佳处方工艺并进行验证。结果:二项式方程拟合度较高(r2=0.911 3,P0.001),预测性好;效应面法优选最佳工艺条件为β-CD/DIP质量比5.7,包合时间5.5 h,包合温度50℃;最佳工艺验证偏差均5%,所得包合物溶解度及释药速度均提高。结论:应用星点设计-效应面优化法能够精确有效地优化DIP-β-CD包合物制备工艺,且最优工艺稳定可行,可用于工业生产。
[Abstract]:Objective: to optimize the preparation process of dipyridamole DIP- 尾-cyclodextrin (尾-CD) inclusion complex by star design-effect surface method. Methods: DIP- 尾 -CD inclusion complex was prepared by saturated aqueous solution method. The preparation process was optimized by star design. The 尾 -CD / dip mass ratio, inclusion time and inclusion temperature were taken as independent variables and the inclusion rate was used as dependent variable, and the multivariate linear regression and binomial equation were used to fit the DIP- 尾 -CD inclusion complex. Select the best prescription process and verify it. Results: the binomial equation had higher fitting degree and good predictability, and the optimum conditions were as follows: 尾 -CD- / dip ratio 5.7, inclusion time 5.5 h, inclusion temperature 50 鈩，

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