人参叶配方颗粒高效液相色谱指纹图谱及化学模式识别研究  

Study on HPLC Fingerprint and Chemical Pattern Recognition of Ginseng Folium Formula Granules

作　　者：黄凯伟 张辉 许树萍 杨惠琳 李仰华 赵伟志 谭沛 HUANG Kaiwei;ZHANG Hui;XU Shuping;YANG Huilin;LI Yanghua;ZHAO Weizhi;TAN Pei(China Resources Sanjiu Medical&Pharmaceutical Co.,Ltd.,Shenzhen,Guangdong,China 518110;China Resources Sanjiu Modern Chinese Medicine Pharmaceutical Co.,Ltd.,Huizhou,Guangdong,China 516000)

机构地区：[1]华润三九医药股份有限公司,广东深圳518110 [2]华润三九现代中药制药有限公司,广东惠州516000

出　　处：《中国药业》2024年第24期58-62,共5页China Pharmaceuticals

基　　金：广东省深圳市科技计划项目[JSGG20191129093418578]。

摘　　要：目的为人参叶配方颗粒的质量控制和评价提供参考。方法采用高效液相色谱(HPLC)法,色谱柱为CORTECS T3柱(150 mm×4.6 mm,2.7μm),流动相为乙腈-0.1%磷酸水溶液(梯度洗脱),流速为1.0 mL/min,检测波长为203 nm,柱温为25℃,进样量为10μL。采用中药色谱指纹图谱相似度评价系统(2012版)建立21批样品的HPLC指纹图谱,确定共有峰,并进行相似度评价。采用聚类分析(CA)法、主成分分析(PCA)法、正交偏最小二乘判别分析(OPLS-DA)法评价不同批次样品的质量差异,并筛选标志物。结果共标定了14个共有峰,指认了4个特征峰,分别为山柰酚-3-O-槐糖苷、人参皂苷Rg1、人参皂苷Re和人参皂苷Rd;21批样品的相似度均大于0.900;CA结果表明21批样品可聚为3类;PCA提取到4个主成分,方差累积贡献率为91.119%;OPLS-DA结果表明山柰酚-3-O-槐糖苷是对人参叶配方颗粒影响较大的标志物。结论该方法简便、可行,重复性、精密度、稳定性较好,可为人参叶配方颗粒质量控制及整体性评价提供参考。Objective To provide a reference for the quality control and evaluation of Ginseng Folium Formula Granules.Methods The high-performance liquid chromatography(HPLC)method was adopted;the chromatographic column was the CORTECS T3 column(150 mm×4.6 mm,2.7μm),the mobile phase was acetonitrile-0.1%phosphoric acid aqueous solution(gradient elution),the flow rate was 1.0 mL/min,the detection wavelength was 203 nm,the column temperature was 25℃,and the injection volume was 10μL.The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(2012 Version)was used to establish HPLC fingerprint of 21 batches of samples,the common peaks were marked,and the similarity evaluation was performed.The quality of samples from different batches was evaluated by the cluster analysis(CA),principal component analysis(PCA),and orthogonal partial least squares-discriminant analysis(OPLS-DA)methods,and the markers were screened.Results A total of 14 common peaks were marked,of which four were identified,including kaempferol-3-O-sophoroside,ginsenoside Rg1,ginsenoside Re and ginsenoside Rd.The similarity of 21 batches of samples was greater than 0.900.The CA showed that 21 batches of samples were clustered into three groups.The PCA showed that four principal components were extracted,with a cumulative variance contribution rate of 91.119%.The OPLS-DA showed that kaempferol-3-O-sophoroside had a significant effect on Ginseng Folium Formula Granules.Conclusion This method is simple,feasible,repeatable,precise and stable,which can provide a reference for quality control and overall evaluation of Ginseng Folium Formula Granules.

关 键 词：人参叶 配方颗粒 指纹图谱 高效液相色谱法 质量评价 化学模式识别 

分 类 号：R917[医药卫生—药物分析学]