中成药2024,Vol.46Issue(2) :365-370.DOI:10.3969/j.issn.1001-1528.2024.02.003

肤痒颗粒中9种成分含量同时测定及其化学模式识别研究

Simultaneous content determination of nine constituents and chemical pattern recognition for Fuyang Granules

肖春霞 黄晓婧 许莉 李婷婷 李及 赵小勤
中成药2024,Vol.46Issue(2) :365-370.DOI:10.3969/j.issn.1001-1528.2024.02.003

肤痒颗粒中9种成分含量同时测定及其化学模式识别研究

Simultaneous content determination of nine constituents and chemical pattern recognition for Fuyang Granules

肖春霞 1黄晓婧 1许莉 1李婷婷 1李及 1赵小勤1
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作者信息

  • 1. 成都市药品检验研究院, 国家药品监督管理局中药材质量监测评价重点实验室, 四川 成都 610045
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摘要

目的 同时测定肤痒颗粒中新绿原酸、咖啡酸、绿原酸、隐绿原酸、羟基红花黄色素A、阿魏酸、洋川芎内酯I、洋川芎内酯H、洋川芎内酯A的含量,并进行化学模式识别.方法 UHPLC分析采用Waters Acquity UPLC© BEH C18色谱柱(150 mm×2.1 mm,1.7 μm);流动相乙腈-0.01%磷酸,梯度洗脱;体积流量 0.4 mL/min;柱温35℃;检测波长 278、322、325、390 nm.再进行热图聚类分析、主成分分析.结果 9 种成分在各自范围内线性关系良好(r>0.999 0),平均加样回收率 93.89%~102.25%,RSD 0.85%~2.88%.同一企业不同批次样品整体质量一致,而不同企业样品之间整体质量差异较大.2 个主成分累积贡献率大于 64%.结论 该方法简便准确,可为肤痒颗粒质量评价提供参考.

Abstract

AIM To simultaneously determine the contents of neochlorogenic acid,caffeic acid,chlorogenic acid,cryptochlorogenic acid,hydroxysafflor yellow A,ferulic acid,senkyunolide I,senkyunolide H and senkyunolide A in Fuyang Granules,and to make chemical pattern recognition.METHODS The UHPLC was performed on a 35℃thermostatic Waters Acquity UPLC©BEH C18 column(150 mm×2.1 mm,1.7 μm),with the mobile phase comprising of acetonitrile-0.01%phosphoric acid flowing at 0.4 mL/min in a gradient elution manner,and the detection wavelengths were set at 278,322,325,390 nm.Then heatmap clustering analysis and principal component analysis were adopted.RESULTS Nine constituents showed good linear relationships within their own ranges(r>0.999 0),whose average recoveries were 93.89%-102.25%with the RSDs of 0.85%-2.88%.Different batches of samples from the same enterprises demonstrated consistent overall qualities,while the overall qualities of samples from different enterprises exhibited obvious differences.CONCLUSION This simple and accurate method can be used for the quality control of Fuyang Granules.

关键词

肤痒颗粒/化学成分/含量测定/UHPLC/热图聚类分析/主成分分析

Key words

Fuyang Granules/chemical constituents/content determination/UHPLC/heatmap clustering analysis/principal component analysis

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基金项目

2021年国家药品抽检计划(国药监药管20211号)

中央补助地方经费项目(2021)()

出版年

2024
中成药
国家食品药品监督管理局,信息中心中成药信息站,上海中药行业协会

中成药

CSTPCD北大核心
影响因子:1.217
ISSN:1001-1528
参考文献量17
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