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参叶补益方的提取工艺优选
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| 篇名： | 参叶补益方的提取工艺优选 |
| TITLE： | Optimization of the extraction process of Shenye buyi formula |
| 摘要： | 目的 优选参叶补益方的提取工艺。方法基于质量源于设计理念，选择芦丁、荷叶碱、芥子碱硫氰酸盐、甘草苷、甘草酸单铵盐含量和出膏率为参叶补益方提取工艺的关键质量属性（CQAs）；采用鱼骨图结合失效模型和效应分析法确定加水量、提取时间和提取次数为关键工艺参数（CPPs）。采用高效液相色谱法检测芦丁、荷叶碱、芥子碱硫氰酸盐、甘草苷、甘草酸单铵盐含量；采用层次分析-熵权法对芦丁等5种成分的含量及出膏率进行综合赋权。采用Box-Behnken响应面法拟合CQAs与CPPs数学模型，筛选提取工艺的操作空间并进行验证。结果优选提取工艺的操作空间为加水量9.5～12倍、提取时间1～1.7h、提取次数3次。经验证，操作空间内优选提取工艺的综合评分分别为89.79、84.93分。结论所得参叶补益方的提取工艺可用于其颗粒剂的开发与生产。 |
| ABSTRACT： | OBJECTIVE To optimize the extraction process of Shenye buyi formula. METHODS Based on the quality by design （QbD） concept， the contents of rutin， nuciferine， sinapine thiocyanate， liquiritin，and glycyrrhizic acid ammonium salt， as well as the extract yield， were selected as the critical quality attributes （CQAs） for the extraction process of Shenye buyi formula. The fishbone diagram combined with the failure model and effect analysis method was adopted to determine the water addition， extraction time and extraction times as critical process parameters （CPPs）. High-performance liquid chromatography was employed to detect the contents of rutin， nuciferine， sinapine thiocyanate， liquiritin， and glycyrrhizic acid ammonium salt. The analytic hierarchy process-entropy weight method was used to comprehensively assign weights to the content of the five components including rutin and the extract yield. The Box-Behnken response surface method was employed to fit the mathematical model between CQAs and CPPs， screen the operational space of the extraction process， and validate it. RESULTS The optimal operational space of the extraction process was 9.5 to 12 times the amount of water added， the extraction time was 1 to 1.7 hours， and the extraction times were 3. Upon verification，the comprehensive scores of the optimal extraction process within the operational space were 89.79 and 84.93， respectively. CONCLUSIONS The extraction process of the Shenye buyi formula can be applied to the development and production of its granule preparations. |
| 期刊： | 2026年第37卷第12期 |
| 作者： | 吴延娆；于明明；牛晓静；段晓颖 |
| AUTHORS： | WU Yanrao，YU Mingming，NIU Xiaojing，DUAN Xiaoying |
| 关键字： | 参叶补益方; 工艺优选; 关键工艺参数; 关键质量属性; 层次分析-熵权法; Box-Behnken响应面法 |
| KEYWORDS： | Shenye buyi formula; process optimization; CPPs; CQAs; AHP-EWM; Box-Behnken response surface method |
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