响应面法结合G1-熵权法优化复方甘草含片的工艺

Process optimization of Compound licorice buccal tablet by Responsive surface method combined with G1-entropy weight method

目的优化复方甘草含片的干燥与成型工艺。方法以甘草苷、甘草酸含量为评价指标,优选甘草浸膏的干燥方法;以填充剂用量、润滑剂、黏合剂、矫味剂用量等作为考察因素,以外观、口感、硬度、崩解时限为评价指标,在单因素考察试验的基础上,应用Box-Behnken响应面设计结合G1-熵权法优化复方甘草含片的成型工艺。结果喷雾干燥为最佳干燥方式;干法制粒优选的辅料种类及配比为:填充剂(甘露醇-乳糖为2:1)占比20%、黏合剂(羧甲基纤维素钠)占比1%、润滑剂(硬脂酸镁)占比1%、矫味剂(阿斯巴甜)占比1.5%,验证试验的综合评分分别为87.48、90.00、88.68,RSD=1.42%。结论优选的甘草浸膏干燥方式与复方甘草含片干法制粒工艺稳定可行,可为该含片的工业生产提供参考。

OBJECTIVE To optimize the drying process and molding process of Compound licorice buccal tablet(CLBT).METHODS The drying method of licorice extract was optimized with the contents of liquiritin and glycyrrhizic acid as evaluation index.Based on the single factor test,the Box-Behnken response surface design combined with Gl-entropy weight method was used to optimize the forming process of CLBT with the proportion of fller,lubricant,binder and taste modifier as the factors.RESULTS Spray drying was the best drying method.The optimal type and proportion of excipients for dry granule are as follows:filler[mannitol-lactose(2:1)]accounted for 20%,binder(sodium carboxymethyl cellulose)accounted for 1%,lubricant(magnesium stearate)accounted for 1%,and taste modifier(aspartame)accounted for 1.5%.The comprehensive scores of verification tests were 87.48,90.00,88.68,and RSD was 1.42%,respectively.CONCLUSIONThe optimal drying method of licorice extract and the dry granuletion process of CLBT are stable and feasible,which can provide reference for the industrial production of CLBT.