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目的采用中心复合设计法优化盐酸环丙沙星海藻酸钠-壳聚糖双层膜的处方。方法考察甘油质量浓度、交联剂CaCl2质量浓度和交联时间对双层膜单位面积的载药量,吸水率,抗张强度,断裂伸长率,水蒸气透过率,药物释放12、24、48 h累积释放度8个指标的影响。用多元线性方程和二次多项式描述各指标及总评“归一值”和3个影响因素之间的数学关系,根据总评“归一值”的最佳数学模型描绘效应面,选择最佳处方,并进行预测分析。结果 3个影响因素和8个评价指标及总评“归一值”之间存在定量关系。优选的最佳条件为甘油质量浓度为47.1 g.L-1,CaCl2质量浓度为95.4 g.L-1,交联时间为4.63 min。优化处方各指标的预测值和目标值接近。结论中心复合设计较好的完成了载药双层膜的处方优化,所建立的模型预测性良好。
Objective To optimize the prescription of sodium cysteic acid-chitosan bilayer membrane by central composite design. Methods The effects of glycerol concentration, crosslinker CaCl2 mass concentration and crosslinking time on drug loading per unit area, water absorption, tensile strength, elongation at break, water vapor transmission rate, drug release 12,24 , 48 h cumulative release of 8 indicators. Multivariate linear equations and quadratic polynomials are used to describe the mathematical relationship between each indicator and the general rating “normalized value ” and the three influencing factors, and the effect surface is depicted according to the best mathematical model of the “normalized value The best prescription, and forecast analysis. Results There was a quantitative relationship between the three influencing factors and the eight evaluation indexes and the general rating ”normalized value ". The optimal conditions for glycerol were 47.1 g.L-1, 95.4 g.L-1 for CaCl2, and 4.63 min for crosslinking. The predicted value and the target value of each index of optimized prescription are close. Conclusion The composite design of the center has completed the prescription optimization of the drug-loaded bilayer membrane, and the model established has good predictability.