基于Box-Behnken响应面法优选疏肝胃安颗粒制备工艺  

Process Optimization of Shugan Wei'an Granules Based on Box-Behnken Response Surface Method

作　　者：柯媛媛 高永跃 罗玉玲 周训蓉 KE Yuan-yuan;GAO Yong-yue;LUO Yu-ling;ZHOU Xun-rong(School of Pharmacy,Guizhou University of Traditional Chinese Medicine,Guiyang 550025,Guizhou China;Department of Pharmacy,the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang 550003,Guizhou China)

机构地区：[1]贵州中医药大学药学院,贵州贵阳550025 [2]贵州中医药大学第二附属医院药学部,贵州贵阳550003

出　　处：《亚热带植物科学》2023年第4期310-317,共8页Subtropical Plant Science

基　　金：医院制剂疏肝胃安颗粒制备工艺和质量标准研究(QZYY-2023-104);医院制剂工艺、质量标准提升及新产品研发(GZEYK-Y[2022]1)。

摘　　要：以柚皮苷含量和总固体收率为指标,通过正交试验优选疏肝胃安颗粒提取工艺的最佳煎煮时间、煎煮次数和加水倍数;利用Box-Behnken响应面法优化颗粒成型工艺的药辅比、辅料比、胶态二氧化硅比例最佳水平,并采用综合加权法计算总评得分。结果表明,疏肝胃安颗粒最佳提取工艺为煎煮3次,第一次加7.5倍水,第二、三次加6倍水,每次煎煮45 min,滤过,浓缩;最佳成型工艺为辅料与浸膏比1:1、可溶性淀粉与糊精比1:1、胶态二氧化硅比例8%。验证3批总评的平均值为0.737,理论预测值为0.766,验证值与预测值相对偏差1.93%(小于5.0%)。优选的疏肝胃安颗粒制备工艺为其大生产提供重要支撑。The preparation process of Shugan Wei'an granules was explored in this paper.Using naringin content and total solid yield as indicators,the optimal extraction process for Shugan Wei'an granules was optimized through orthogonal experiments,including the optimal decoction time,decoction frequency,and water addition ratio.And the Box-Behnken response surface method was used to optimize the optimal levels of the drug-excipient ratio,excipient material ratio and colloidal silica ratio for particle forming process,and using the comprehensive weighting method to calculate the overall evaluation score.The optimum extraction process of Shugan Wei'an granules was as follows:decocting 3 times,adding 7.5 times water for the first time,adding 6 times water for the second and third times,decocting 45 min each time,filtering and concentrating.The optimum molding process was as follows:the ratio of excipients to extract was 1:1,the ratio of soluble starch to dextrin was 1:1,and the ratio of colloidal silica was 8%.The average value of the three batches of total evaluation was 0.737,the theoretical prediction value was 0.766,and the relative deviation between the verification value and the prediction value was 1.93%(less than 5.0%).This experiment optimized the preparation process of Shugan Wei'an granules,which can provide important theoretical support for the large-scale production of Shugan Wei'an granules.

关 键 词：疏肝胃安颗粒 Box-Behnken响应面法 成型工艺 湿法制粒 正交试验 

分 类 号：R93[医药卫生—生药学]