心脉通胶囊的HPLC指纹图谱研究与化学模式识别

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Ⅱ_A，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。

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,tanshinoneⅡ_A,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.

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