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引用本文:戴泰宇,赵敏彤,颉佳乐,刘镇,胡银洲,陆晓燕,龚行楚.基于AQbD理念研发黄酒中14种酚酸及黄酮类成分的液相色谱分析方法[J].中国现代应用药学,2026,43(17):49-58.
DAI TAIYU,ZHAO MINTONG,XIE JIALE,LIU ZHEN,HU YINZHOU,LU XIAOYAN,龚行楚.Analysis Method of 14 Phenolic Acids and Flavonoids in Huangjiu Based on the Analytical Quality by Design[J].Chin J Mod Appl Pharm(中国现代应用药学),2026,43(17):49-58.
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基于AQbD理念研发黄酒中14种酚酸及黄酮类成分的液相色谱分析方法
戴泰宇1, 赵敏彤2, 颉佳乐2, 刘镇3, 胡银洲3, 陆晓燕2, 龚行楚2
1.天津中医药大学;2.浙江大学;3.绍兴市食品药品检验研究院
摘要:
目的 基于分析质量源于设计(AQbD)理念建立同时测定黄酒中14种酚酸及黄酮类成分的高效液相色谱-二极管阵列检测器(HPLC-DAD)定量方法。方法 采用确定性筛选设计(DSD)对柱温、流量及梯度洗脱程序等6个因素进行优化,考察其对关键方法属性(分离度与出峰时间)的影响,构建定量模型,并运用蒙特卡洛法计算方法可操作设计区域(MODR)。结果 方法学验证结果表明,各成分线性关系良好(R2≥0.9994),精密度、稳定性及重复性相对标准偏差(RSD)均低于2.0%,平均加标回收率为92.3%~104.9%。应用所建方法测定10批次黄酒样品中多酚含量,结果显示香草酸含量显著高于其他成分。结论 建立的方法准确、可靠,适用于黄酒中酚酸和黄酮类成分的定量分析,为其质量控制和健康功能评价提供技术支撑。
关键词:  黄酒  分析质量源于设计  确定性筛选设计  酚酸  黄酮
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Analysis Method of 14 Phenolic Acids and Flavonoids in Huangjiu Based on the Analytical Quality by Design
DAI TAIYU,ZHAO MINTONG,XIE JIALE,LIU ZHEN,HU YINZHOU,LU XIAOYAN,龚行楚
1.Tianjin University of Traditional Chinese Medicine;2.Zhejiang University
Abstract:
To establish an HPLC-DAD method based on Analytical Quality by Design (AQbD) for simultaneous determination of 14 phenolic acids and flavonoids in Huangjiu. METHODS Six critical factors including column temperature and gradient elution program were optimized using Definitive Screening Design (DSD). Quantitative models were developed, and the Method Operable Design Region (MODR) was calculated by Monte Carlo simulation. RESULTS Method validation confirmed excellent linearity (R2 ≥ 0.9994), precision RSD < 2.0%, and recovery rates of 92.3–104.9%. Analysis of 10 batches revealed significantly higher vanillic acid content than other components. CONCLUSION The developed method is accurate and reliable, providing effective technical support for quality control and health function assessment of Huangjiu.
Key words:  Huangjiu  analytical quality by design  definitive screening design  phenolic acid  flavone
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