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期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nicpbp.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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心脉通胶囊的HPLC指纹图谱研究与化学模式识别

HPLC fingerprint and chemical pattern recognition of Xinmaitong capsules

作者: 李明月 
作者(英文):LI Ming-yue
分类号:R917
出版年·卷·期(页码):2020,40 (6):1104-1112
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的: 建立心脉通胶囊高效液相色谱(HPLC)指纹图谱分析方法,为评价其质量提供依据。方法: 采用Agilent SB-C18色谱柱(250 mm×4.6 mm,5 μm);以乙腈(A)-0.05%磷酸水溶液(B)为流动相,梯度洗脱;体积流量1.0 mL·min-1;检测波长254 nm;柱温40℃;进样量20 μL。通过相似度评价,结合化学模式分析对19批次心脉通胶囊指纹图谱进行质量评价。结果: 建立心脉通胶囊指纹图谱,共标定25个共有峰,指认了芦丁、藁本内酯、葛根素、咖啡酸、丹酚酸B、槲皮素、丹参酮ⅡA,三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1、橙黄决明素11个有效成分;19批样品相似度为0.991 0~0.994 0,通过聚类分析(HCA)可将19批样品聚成2类,结合主成分分析(PCA)、偏最小二乘法-判别分析(PLS-DA)发现7个成分是造成不同批次样品差异性的主要标记物。结论: 所建立的HPLC指纹图谱及化学模式识别专属性强,可用于心脉通胶囊的定性定量分析。

-----英文摘要:---------------------------------------------------------------------------------------

Objective: To establish an HPLC fingerprint of Xinmaitong capsules for reference of the effective quality control.Methods: The analysis was performed on Agilent SB-C18(250 mm×4.6 mm,5 μm)column with mobile phase consisting of acetonitrile and 0.05% phosphoric acid solution with gradient elution at 0.3 mL·min-1.The detection wavelength was 254 nm,the column temperature was 40℃,and the injection volume was 20 μL.Similarity evaluation combined with chemical pattern recognition was used to evaluate the fingerprint of 19 batches of Xinmaitong capsules.Results: HPLC fingerprint of Xinmaitong capsules was established with 25 common peaks,and 12 of them were identified as rutoside,ligustilide,puerarin,caffeic acid,salvianolic acid B,quercetin,tanshinoneⅡA,notoginsenoside R1,ginsenoside Rg1,ginsenoside Rb1 and aurantio-obtusin.The similar degrees of 19 batches of samples were 0.991 0-0.994 0.The samples were classified into two groups by hierarchical cluster analysis(HCA)combined with principal component analysis(PCA)and discriminant analysis of partial least squares(PLS-DA)and seven components were the main markers that cause differences in the different batches of samples.Conclusion: Establishment of fingerprint and application of chemical pattern recognition are specific,which can be used for qualitative and quantitative analysis of Xinmaitong capsules.

-----参考文献:---------------------------------------------------------------------------------------
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