| 基于QbD理念的散偏汤提取工艺设计空间预测 |
| 投稿时间：2023-02-22 点此下载全文
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| 引用本文：孙萌,刘雪纯,赵玥瑛,张晴,席铖,董爽,张馨雨,杜守颖,白洁,陆洋.基于QbD理念的散偏汤提取工艺设计空间预测[J].中国现代中药,2024,26(2):348-356 |
| DOI：10.13313/j.issn.1673-4890.20230222002 |
| 摘要点击次数: 244 |
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| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 孙萌 |
SUN Meng |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 刘雪纯 |
LIU Xue-chun |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 赵玥瑛 |
ZHAO Yue-ying |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 张晴 |
ZHANG Qing |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 席铖 |
XI Cheng |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 董爽 |
DONG Shuang |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 张馨雨 |
ZHANG Xin-yu |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 杜守颖 |
DU Shou-ying |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 白洁* |
BAI Jie |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 陆洋* |
LU Yang |
北京中医药大学 中药学院，北京 102488 |
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China |
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| 基金项目:国家自然科学基金项目（82173989） |
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| 中文摘要:目的 预测散偏汤提取工艺的设计空间。方法 基于质量源于设计和设计空间理念，采用鱼骨图结合失效模型与效应分析的方法确定提取次数、提取时间、加水倍量为散偏汤提取工艺的关键工艺参数，以阿魏酸、芥子碱硫氰酸盐、甘草苷、甘草酸的含量及出膏率为关键质量属性，采用Box-Behnken响应面法试验设计拟合数学模型，考察其相互关系，建立散偏汤提取工艺设计空间。结果 依据数学模型建立了散偏汤提取工艺设计空间，在此空间内取点验证，发现单个处方阿魏酸、芥子碱硫氰酸盐、甘草苷、甘草酸的质量分数分别为0.450‰、0.787‰、0.248‰、0.451‰，出膏率为23.83%，符合关键质量属性的要求。结论 建立的设计空间可为散偏汤放大生产和质量控制提供参考。 |
| 中文关键词:质量源于设计 设计空间 散偏汤 提取工艺 |
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| Prediction of Extraction Process Design Space of Sanpian Decoction based on Quality by Design |
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| Abstract:Objective To predict the design space of the extraction process of Sanpian Decoction.Methods Based on the theory of quality by design and design space, the failure model of fishbone diagram combined with risk priority number was used to determine the number of extractions, extraction time, and amount of water added as the critical parameters of the extraction process of Sanpian Decoction, and the content of ferulic acid, sinapine thiocyanate, liquiritin and glycyrrhizic acid and extraction yields as the critical quality attributes. Box-Behnken response surface method was used to design an experimental fitting mathematical model. The relationship between them was investigated and the design space of the extraction process of Sanpian Decoction was established.Results The design space of the extraction process of Sanpian Decoction was established according to the mathematical model. The verification test results showed that the mass fractionof ferulic acid, sinapine thiocyanate, liquiritin, and glycyrrhizic acid in the single prescription were 0.450‰, 0.787‰, 0.248‰ and 0.451‰, respectively. The extract yield was 23.83%, which met the requirements of critical quality attributes.Conclusion The established design space provides a reference for the scale-up production and quality control of Sanpian Decoction. |
| keywords:quality by design design space Sanpian Decoction extraction process |
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