柴玉爽;曾瑚瑚;何源峰;尚晓;万婷;尹震;范春林;叶文才;
CHAI Yu-shuang;ZENG Hu-hu;HE Yuan-feng;SHANG Xiao;WAN Ting;YIN Zhen;FAN Chun-lin;YE Wen-cai;Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., Ltd.;Guangdong Province Key Laboratory of Pharmacodynamic Constituents of TCM and New Drugs Research, Jinan University;

• 1:广州白云山中一药业有限公司
• 2:暨南大学广东省中药药效物质基础与创新药物研究重点实验室

摘要(Abstract)：

建立中一牌安宫牛黄丸的超高效液相(UPLC)指纹图谱分析方法,结合化学模式识别对其质量进行评价。采用UPLC,色谱柱为Poroshell 120 EC-C_(18)(2.1 mm×100 mm, 2.7μm),以甲醇-0.1%甲酸水为流动相梯度洗脱,流速为0.4 mL·min~(-1),柱温为30℃,检测波长为254 nm。采用"中药色谱指纹图谱相似度评价系统(2004A版)"结合SIMCA13.0软件进行聚类分析、主成分分析和偏最小二乘法-判别分析,对24批安宫牛黄丸样品进行分析,确定了25个共有峰。经对照品和液质联用技术对其中的17个色谱峰进行结构确认,结果显示24批样品的相似度均大于0.980,样品可以聚为3类,黄芩苷、小檗碱、药根碱、汉黄芩素和汉黄芩苷是造成不同批次样品间差异的标志性成分。该方法简便、快速、准确性高、重现性好,可为中一牌安宫牛黄丸的质量标准提升提供科学依据。
To establish the UPLC fingerprint of Zhongyi Angong Niuhuang Pills, in order to evaluate its quality by chemical pattern recognition. The method was developed on a column of Poroshell 120 EC-C_(18), with methanol-0.1% formic acid solution as the mobile phase for gradient elution at a flow rate of 0.4 mL·min~(-1). The column temperature was 30 ℃,and the detective wavelength was 254 nm. The similarity of 24 batches of Angong Niuhuang Pills was compared by using Traditional Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System(2004 A). Hydrophobic cluster analysis,principal components analysis and partial least squares discriminant analysis were conducted by using SIMCA 13.0 software to investigate different components among these products. The UPLC characteristic fingerprint was established in this study. And 17 common peaks were identified by standard reference and UPLC-MS. The similarity of 24 batches samples were above 0.980,which can be classified into three categories for pattern recognition. Baicalin,berberine,jatrorrhizine,wogonin and wogonoside were identified as the main markers that cause differences of various batches. The method is simple,rapid,accurate and reproducible,and can provide scientific basis for improving the quality standard of Zhongyi Angong Niuhuang Pills.

关键词(KeyWords)： 安宫牛黄丸;UPLC;特征指纹图谱;化学模式识别
Angong Niuhuang Pills;ultra performance liquid chromatography;fingerprint;chemical pattern recognition

Abstract:

Keywords:

基金项目(Foundation): 广州市科技计划项目(201710010119,201704030047)

作者(Author): 柴玉爽;曾瑚瑚;何源峰;尚晓;万婷;尹震;范春林;叶文才;
CHAI Yu-shuang;ZENG Hu-hu;HE Yuan-feng;SHANG Xiao;WAN Ting;YIN Zhen;FAN Chun-lin;YE Wen-cai;Guangzhou Baiyunshan Zhongyi Pharmaceutical Co., Ltd.;Guangdong Province Key Laboratory of Pharmacodynamic Constituents of TCM and New Drugs Research, Jinan University;

Email:

DOI: 10.19540/j.cnki.cjcmm.20191217.305

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