基于HPLC指纹图谱结合多种化学模式识别评价生脉饮(党参方)质量

目的：建立多批次生脉饮（党参方） HPLC指纹图谱并采用多种化学计量学分析评价多厂家多批次生脉饮（党参方）的整体质量。方法：采用Ultimate XB-C₁₈色谱柱（4.6 mm×250 mm，5 μm），流动相为乙腈-0.15%甲酸水溶液，检测波长为260 nm，流速0.8 mL·min^-1，柱温20℃，对多批不同厂家和来源的生脉饮（党参方）制剂进行分析，建立中药色谱指纹图谱，并结合聚类分析、主成分分析与偏最小二乘法判别分析对生脉饮（党参方）质量进行评价。结果：建立了生脉饮（党参方） HPLC指纹图谱，确定了23个共有峰，并指认了其中7个色谱峰；多批次生脉饮（党参方） HPLC指纹图谱的相似度为0.061~0.798；聚类分析与主成分分析结果一致，结合正交偏最小二乘法判别分析发现3类主成分中包含的7个成分峰是造成不同批次生脉饮（党参方）质量差异的主要标志物。在多指标成分定量分析方法学考察结果中，7种指标性成分的加样回收率在97.32%~101.26%，RSD为1.89%~3.56%。结论：不同批次的生脉饮（党参方）之间虽有一定的相关性，但存在质量差异。生脉饮（党参方）检测方法的建立可以为其质量控制及评价提供参考依据，且具有一定的药用开发价值，为其进一步药效及制剂研究奠定基础。

Evaluation of Shengmaiyin (Dangshen Recipe) quality based upon high performance liquid chromatography fingerprint and multiple chemical pattern recognition

OBJECTIVE To establish high performance liquid chromatography (HPLC) fingerprint of multiple batches of Shengmaiyin (Dangshen recipe) and evaluate its overall quality from many plants and batches through chemometrics.METHODS Using Ultimate XB-C₁₈ column (4.6 mm×250 mm, 5 μm), mobile phase was acetonitrile-0.15% formic acid aqueous solution, detection wavelength 260 nm, flow rate 0.8 mL·min^-1 and column temperature 20℃, multiple batches of Shengmaiyin (Dangshen recipe) preparations from different manufacturers and sources were analyzed and the chromatographic fingerprints of traditional Chinese medicine established. Cluster, principal component and partial least square discriminant analyses were combined.RESULTS HPLC fingerprint of Shengmaiyin (Dangshen recipe) was established with 23 common peaks and 7 chromatographic peaks. The similarity of HPLC fingerprints of multiple batches of Shengmaiyin (Dangshen recipe) was 0.061-0.798; Cluster analysis agreed with the results of principal component analysis. In conjunction with orthogonal partial least square discriminant analysis, 7 component peaks in 3 principal components were responsible for quality difference of different batches of major marker. In the results of quantitative analysis methodology of multi-index components, the recoveries of 7 index components ranged from 97.32%-101.26% with RSD values ranging from 1.89%-3.56%.CONCLUSION Despite quality differences, some correlation exists between different batches of Shengmaiyin (Dangshen recipe). The establishment of detection method of Shengmaiyin (Dangshen recipe) provides references for its quality control and evaluation and has certain medicinal development value.