Abstract: 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.

Key words: Shugan Wei'an granules, Box-Behnken response surface method, molding process, wet granulation, orthogonal test

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。

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