目的 评价现代工艺与传统制法制得产品质量的一致性，从质量源于设计的理念出发，应用Box-Behnken响应面试验设计结合基准关联度和层次分析法（AHP）-熵权法，确定经典名方半夏泻心汤（Banxia Xiexin Decoction，BXD）的提取工艺参数。方法 以BXD中小檗碱、黄芩苷、甘草酸含量及出膏率和指纹图谱相似度为关键质量属性，以料液比、提取时间、提取次数为关键工艺参数，采用单因素实验确定各因素水平，Box-Behnken设计试验、基准关联度和AHP-熵权法确定指标权重系数，进行综合评分。根据综合评分建立函数模型，反映各因素与响应值之间的关系，优化提取工艺参数并进行验证。结果 Box-Behnken响应面连用基准关联度和AHP-熵权法建立的工艺评价函数模型：综合评分=SR_i出膏率×41.7%+SR_i小檗碱×41.5%+SR_i黄芩苷×6.1%+SR_i甘草酸×5.2%+SR_{i指纹图谱相似度}×5.5%，该模型稳定可靠，确定最佳提取工艺为全方饮片加7倍量水，提取0.5 h，提取1次。验证试验综合评分均值为87.37，RSD为2.09%，符合基准物质标准的要求，且方法具有适用性。结论 筛选的BXD现代提取工艺参数具有可行性，为其他经典名方的开发利用提供理论依据。

Objective To evaluate the consistency of the quality of preparations manufactured by modern technology and traditional methods, starting from the concept that quality by design, the extraction process parameters of the classic famous prescription Banxia Xiexin Decoction (半夏泻心汤, BXD) were determined by using Box-Behnken design-response surface method combined with standard relation and analytic hierarchy process (AHP)-entropy method. Methods The content of berberine, baicalin and glycyrrhizic acid, extraction rate and the similarity of fingerprints were taken as the key evaluation indexes, the solid-liquid ratio, the extraction time and the extraction times were taken as the experimental factors, the different levels of each factor were determined by single factor test. Box-Behnken design-response surface method, standard relation and AHP entropy method were used to determine the weight and conduct comprehensive scoring. According to the comprehensive score, a functional model was established to reflect the relationship between each factor and comprehensive score, and the extraction process parameters were optimized and verified. Results A process evaluation function model was established by using Box-Behnken experimental design combined with standard relation and AHP-entropy method as follow:comprehensive score=SR_{ipaste yield}×41.7% + SR_iberberine×41.5% + SR_ibaicalin×6.1% + SR_{iglycyrrhizinic acid}×5.2% + SR_{ifingerprint similarity}×5.5%. The function model was stable and reliable. The optimal extraction process was to add seven times of water to the whole decoction pieces, extract for 0.5 h and once. The average score of the validation test was 87.37, and the RSD was 2.09%, which met the requirements of the reference material standard, and the method was applicable. Conclusion The modern extraction parameters of BXD screened by this method were feasible, wich provided a theoretical basis for the development and utilization of other classic prescriptions.

R283.6

国家重点研发计划项目（2021YFE0201000）