均匀设计和回归分析优化安神宁软胶囊的制备工艺

Optimization of Preparation Process for Anshenning Soft Capsule with Uniform Design and Regression Analysis

目的研究安神宁软胶囊的最佳制备工艺。方法采用均匀实验设计和多元逐步回归分析,以内容物混悬液的沉降体积比和流动性评价为指标,考察药物与分散介质的比例、助悬剂的用量和润湿剂的用量对内容物稳定性的影响;以软胶囊崩解时限和加速试验条件下的崩解时限二者的综合评分为指标,考察明胶-甘油、明胶-纯化水比例以及熔胶温度对囊皮溶解性能的影响。结果安神宁软胶囊内容物处方为:药物干粉与大豆油比例为1:1.5,助悬剂蜂蜡用量为内容物质量分数的4%,润湿剂大豆磷脂用量为内容物质量分数的2%。软胶囊囊皮处方为明胶:甘油:水=1:0.5:1(以质量比计算)。结论均匀设计和回归模型可以对实验结果进行高精度预测,优化了安神宁软胶囊的制备工艺。

Objective To study the best preparation process for anshenning soft capsule.Methods The uniform design and multiple stepwise regression analysis were applied to investigate the influences of the ratio between extract and diluents,suspending agent and wetting agent on the physical stability of the content by using sedimentation ratio and the fluidity evaluation of the content suspension as test indexes.With the comprehensive evaluation about the disintegration and the disintegration under the accelerated trials of the soft capsule as the marker,the ratio between gelatin and glycerol,gelatin and water,the temperature of gelatin melting were investigated to test their influences on the solubility of capsule shell.Results The final formulation of anshenning soft capsule was ascertained as follows：the ratio of the medicine powder to soybean oil was 1：1.5,beeswax as the suspending agent accounting for 4% of the suspension,lecithin as the wetting agent accounting for 2% of the suspension.The final formulation of capsule shell was fixed as follows：gelatin：glycerol：water = 1：0.5：1（W/W）.Conclusion The uniform design and regression model can be used to precisely predict the test results,and optimize the preparation process of anshenning soft capsule.