响应面法优化改性明胶软胶囊囊壳制备工艺

Optimization of preparation of modified gelatin soft capsule shell by response surface methodology

目的制备改性明胶软胶囊囊壳,并对其进行处方优化。方法在单因素试验确定的优化范围基础上,以甲醛处理后胶片的崩解时间、胶片的弹性模量和硬度作为考察指标,对囊壳的改性剂琥珀酸酐添加量,甘油添加量,胶液pH进行Box-Behnken响应面处方分析,优化制备工艺。结果得到最佳制备工艺条件为:琥珀酸酐添加量为明胶的5.5%,甘油添加量为明胶的35%,胶液pH为5.20,得到的改性明胶软胶囊囊壳具有优异的抗甲醛性能,且力学性能良好,可以延缓软胶囊的交联老化现象。结论本研究通过响应面分析法将囊壳的力学特性和抗醛特性结合起来,分析试验指标与多个试验因素间的回归关系,研究函数的响应面和等高线来选择试验设计中的最优化条件,为琥珀酰明胶软胶囊的制备奠定了理论基础。

Objective To prepare modified gelatin soft capsule shell and optimize its formulation.Methods Based on the optimization range determined by single factor experiment,the Box-Behnken response surface method was used to analyze the amount of succinic anhydride,glycerin and pH of the capsules,with the disintegration time after formaldehyde treatment,elastic modulus and hardness of the film as the investigation indexes to optimize the preparation.Results The optimum conditions were as follows:the amount of succinic anhydride was 5.5%that of gelatin,glycerol was 35%that of gelatin,and the pH of glue solution was 5.20.The modified gelatin soft capsule shell under this condition showed excellent formaldehyde resistance and good mechanical properties,which might delay the cross-linking aging of the soft capsules.Conclusion In this study,the mechanical properties and formaldehyde resistance properties of the capsule shell are combined by response surface analysis,the regression relationship between test indexes and multiple test factors was analyzed,and the response surface and contour lines of the function were studied to select the optimal conditions in the test design,which laid a theoretical foundation for succinyl gelatin soft capsules.