秦建平;李家春;吴建雄;吴素素;黄文哲;王振中;萧伟;
QIN Jian-ping;LI Jia-chun;WU Jian-xiong;WU Su-su;HUANG Wen-zhe;WANG Zhen-zhong;XIAO Wei;Jiangsu Kanion Pharmaceutical Co. ,Ltd.;State Key Laboratory of Pharmaceutical Process New-tech for Chinese Medicine;

• 1:江苏康缘药业股份有限公司
• 2:中药制药过程新技术国家重点实验室

摘要(Abstract)：

建立不同厂家龙血竭UPLC指纹图谱,为其质量控制提供比较全面的评价方法。采用Phenomenex Kinetex 2.6μC18100A色谱柱,以乙腈-水梯度洗脱,流速1.7 m L·min-1,柱温40℃,检测波长为280 nm。利用化学计量学方法对色谱数据进行相似度分析、聚类分析和主成分分析。采用该方法测定了18批龙血竭,提取15个色谱峰作为指纹图谱共有峰,采用LC-QTOF MS方法指认了13个共有峰;其中15批样品相似度大于0.9;18批样品可大致分为4类。该法重复性好,简便可靠,可以为不同厂家龙血竭的质量控制和评价提供依据。
This study is to establish an UPLC fingerprint of Resina Draconis from different manufacturers,whichcan provide a comprehensive evaluation for its quality control. The analysis was performed on a Phenomenex Kinetex 2. 6 μ C18100 A column by agradientelution program withacetonitrile-water asmobile phase at a flow rate of 1. 7 m L·min-1. The column temperature was 40 ℃ and the detection wavelengthwas 280 nm. The fingerprints of 18 batches of DraconisResina were further evaluated by chemometrics methods including similarity analysis( SA),hierarchical clustering analysis( HCA) and principal component analysis( PCA). As a result,there were 15 common peaks,13 of which had been identified by LC-Q-TOF MS,and the similarity degrees of 15 batches of the samples was more than 0. 9,and the samples were divided into 4 clusters by their quality difference. The method is reproducible,simple and reliablethat it can be used for quality control and evaluation of Resina Draconis from different manufacturers.

关键词(KeyWords)： 龙血竭;UPLC;指纹图谱;化学计量学;质量评价
Resina Draconis;UPLC;fingerprint;chemometrics;quality evaluation

Abstract:

Keywords:

基金项目(Foundation): 国家“重大新药创制”科技重大专项(2011ZX09201-201-20)

作者(Author): 秦建平;李家春;吴建雄;吴素素;黄文哲;王振中;萧伟;
QIN Jian-ping;LI Jia-chun;WU Jian-xiong;WU Su-su;HUANG Wen-zhe;WANG Zhen-zhong;XIAO Wei;Jiangsu Kanion Pharmaceutical Co. ,Ltd.;State Key Laboratory of Pharmaceutical Process New-tech for Chinese Medicine;

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DOI:

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