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目的星点设计-效应面法优化银杏酮酯(GBE50)的β-环糊精(β-CD)包合物的制备工艺。方法以饱和水溶液法制备GBE50-β-CD包合物,采用星点设计优化制备工艺,以β-CD与GBE50的投料质量比、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,并根据最佳数学模型描绘效应面,选择最佳处方工艺进行验证试验。结果二项式方程拟合度较高,预测性好,r=0.966;效应面法优选出的最佳工艺条件为β-CD与GBE50的投料质量比3∶1,包合时间6 h,包合温度60℃。最佳工艺验证试验结果与二项式拟合方程预测值偏差为1.07%。结论应用星点设计-效应面优化法能够精确有效地优化GBE50-β-CD包合物的制备工艺,优选出的最佳工艺稳定可行,可用于工业生产。
Aim To design and optimize the preparation of β-cyclodextrin (β-CD) inclusion compound of GBE50 by response surface methodology. Methods The GBE50-β-CD inclusion complex was prepared by saturated aqueous solution method. The star point design was used to optimize the preparation process. The inclusion ratio of β-CD to GBE50, inclusion time and inclusion temperature were used as independent variables Variables, respectively, multiple linear regression and binomial equation fitting, and according to the best mathematical model depicting the effect surface, select the best prescription process validation test. Results The binomial equation fitted well and the prediction was good, r = 0.966. The optimum process conditions of effect surface method were as follows: the mass ratio of β-CD to GBE50 was 3:1, the inclusion time was 6 h, The temperature is 60 ℃. The deviation of the best process validation test from the binomial fitting equation was 1.07%. Conclusions The preparation of GBE50-β-CD inclusion complex can be optimized accurately and effectively by using the star-point design-response surface optimization method. The optimum process is stable and feasible and can be used in industrial production.