指纹图谱和多成分定量结合化学模式识别法评价清肺达原颗粒质量

Quality Evaluation of Qingfei Dayuan Granules by Fingerprint and Multi-Component Quantitative Method Combined with Chemical Pattern Recognition

目的:建立清肺达原颗粒的指纹图谱及多成分含量测定方法,并结合化学模式识别分析,对清肺达原颗粒质量进行评价。方法:采用超高液相色谱法,建立清肺达原颗粒的指纹图谱,并按中药色谱指纹图谱相似度评价系统(2012版)对15批供试品样品进行相似度分析评价;通过对照品比对指认了6个化学成分,并测定样品中6种成分的含量;采用SPSS 21.0软件进行聚类分析、主成分分析,对其质量进行分析评价。结果:在不同批次清肺达原颗粒指纹图谱中,确定了12个共有峰,指认了6个共有峰分别为芒果苷、芍药苷、橙皮苷、黄芩苷、大黄素、和厚朴酚,样品中上述6种成分在相应的浓度范围内线性关系良好,含量测定方法的精密度、重复性均较好,且准确度高。化学计量学聚类分析结果显示,15批样品聚为2大类;主成分分析显示15批样品综合排名位居前5的依次是YP05、YP12、YP14、YP15、YP04。结论:建立了清肺达原颗粒指纹图谱、多成分含量测定方法,并结合聚类分析、主成分分析等化学模式识别方法,可以比较全面、高效地对清肺达原颗粒的质量进行评价,为其整体质量控制提供参考依据。

Objective:The fingerprint and multi-component determination method of Qingfei Dayuan Granules were established,and the quality of Qingfei Dayuan granules was evaluated by chemical pattern recognition analysis.Methods:The fingerprint of Qingfei Dayuan Granules was established by ultra-high liquid chromatography,and 15 batches of samples were evaluated by the Traditional Chinese Medicine(TCM)chromatographic fingerprint similarity evaluation system(2012).Six chemical components were identified by comparison of reference materials,and the content of six components in the sample was determined.SPSS 21.0 software was used for cluster analysis and principal component analysis to evaluate its quality.Results:Identified 12 common peaks,and identified the six common peaks of mangiferin,paeoniflorin,hesperidin,baicalin,emodin,and honokiol in different batches of Qingfei Dayuan Granules fingerprint.The above six components in the samples had good linear relationships within the corresponding concentration range,and the content determination method had good precision,repeatability,and high accuracy.Stoichiometric cluster analysis showed that 15 batches of samples were clustered into two categories.Principal component analysis showed that YP04,YP05,YP12,YP14,and YP15 ranked in the top 5 in the comprehensive ranking of 15 batches of samples.Conclusion:The established fingerprint,multi-component content determination method,and chemical pattern recognition analysis of Qingfei Dayuan Granules can evaluate the quality of Qingfei Dayuan Granules comprehensively and efficiently,and provide a reference for its overall quality control.