血脉疏通颗粒UPLC-ELSD指纹图谱的建立及9种成分含量测定  

Establishment of UPLC-ELSD Fingerprint and Determination of 9 Components of Xuemai Shutong Granules

作　　者：李素梅 毕晓黎 陈伟韬 胥爱丽 肖观林 张靖年 江洁怡 李养学 LI Sumei;BI Xiaoli;CHEN Weitao;XU Aili;XIAO Guanlin;ZHANG Jingnian;JIANG Jieyi;LI Yangxue(Guangdong Second Traditional Chinese Medicine Hospital(Guangdong Province Engineering Technology Research Institute of Traditional Chinese Medicine)/Guangdong Provincial Key Laboratory of Research and Development in Traditional Chinese Medicine,Guangzhou 510095,China)

机构地区：[1]广东省第二中医院(广东省中医药工程技术研究院)/广东省中医药研究开发重点实验室,广州510095

出　　处：《医药导报》2025年第4期648-655,共8页Herald of Medicine

基　　金：广东省中医药局科研项目(20231038);2021年省属科研机构稳定性支持项目(粤财科教[2021]113号)。

摘　　要：目的建立血脉疏通颗粒超高效液相色谱-蒸发光散射检测器(UPLC-ELSD)指纹图谱,并同时测定其中9种成分的含量。方法采用UPLC-ELSD法,建立11批血脉疏通颗粒指纹图谱及测定其中9种成分的含量,并采用相似度评价软件、系统聚类分析、主成分分析、正交偏最小二乘判别分析评价不同批次制剂质量。结果11批次血脉疏通颗粒UPLC-ELSD指纹图谱相似度为0.929~0.978,标定了17个共有峰,确认了其中11个色谱峰:3号峰为三七皂苷R_(1)、4号峰为人参皂苷Rg_(1)(Re)、5号峰为三七皂苷R_(2)、6号峰为人参皂苷Rb_(1)、9号峰为黄芪甲苷、10号峰为人参皂苷Rk_(3)、11号峰人参皂苷Rh_(4)、12号峰为20(S)-人参皂苷Rg_(3)、13号峰为20(R)-人参皂苷Rg_(3)、14号峰为人参皂苷Rk_(1)、15号峰为人参皂苷Rg_(5)。化学计量学分析将11批样品分为2类,提取了2种成分主要反映了17个共有峰的大部分信息,并筛出影响质量差异的10个成分峰。含量测定中9个成分在各自的质量范围内线性关系良好(r>0.9992),平均回收率为95.02%~97.78%,RSD 0.69%~1.70%(n=6);11批次血脉疏通颗粒中三七皂苷R_(1)、三七皂苷R_(2)、人参皂苷Rb_(1)、黄芪甲苷、人参皂苷Rh_(4)、20(S)-人参皂苷Rg_(3)、20(R)-人参皂苷Rg_(3)、人参皂苷Rk_(1)、人参皂苷Rg_(5)含量分别为0.0875~0.1876、0.4943~0.6886、0.4481~0.7055、0.1922~0.2708、1.4925~2.0776、0.3160~0.4638、0.2545~0.3820、0.1176~0.1639、3.4077~4.7064 mg·g^(-1)。结论所建立的指纹图谱及含量测定方法准确、可靠,可完善血脉疏通颗粒质量标准,为全面评价其质量提供参考。Objective To establish the fingerprint of Xuemai Shutong granules by UPLC-ELSD and determine the contents of 9 components in the preparation simultaneously.Methods The UPLC-ELSD was used to establish the fingerprint of Xuemai Shutong granules,and determine the content of its 9 components.The similarity evaluation system,systematic,cluster analysis,principal component analysis and orthogonal partial least squares discriminant analysis were used to evaluate the quality of different batches of preparation.Results The similarity degrees of UPLC-ELSD fingerprints of 11 batches of Xuemai Shutong granules were from 0.929 to 0.978,17 common peaks were calibrated,of which 11 peaks were identified∶peak 3(notoginsenoside R_(1)),peak 4[ginsenoside Rg_(1)(Re)],peak 5(notoginsenoside R^(2)),peak 6(ginsenoside Rb_(1)),peak 9(astragalosideⅣ),peak 10(ginsenoside Rk_(3)),peak 11(ginsenoside Rh_(4)),peak 12[20(S)-ginsenoside Rg_(3)],peak 13[20(R)-ginsenoside Rg_(3)],peak 14(ginsenoside Rk_(1)),peak 15(ginsenoside Rg_(5)).The stoichiometric analysis divided 11 batches of samples into 2 classes,and the 2 principal components in PCA analysis reflected the information of 17common peaks,10 peaks which affected the quality difference are screened out.The linear relationship of the 9 components was good in their respective quality ranges in the content analysis(r>0.9992),the average recovery rate were between 95.02%-97.78%and the RSD were 0.69%-1.70%(n=6).The contents of notoginsenoside R_(1),notoginsenoside R_(2),ginsenoside Rb_(1),astragalosideⅣ,ginsenoside Rh_(4),20(S)-ginsenoside Rg_(3),20(R)-ginsenoside Rg_(3),ginsenoside Rk_(1),ginsenoside Rg_(5) in the 11 batches of Xuemai Shutong granules were 0.0875-0.1876,0.4943-0.6886,0.4481-0.7055,0.1922-0.2708,1.4925-2.0776,0.3160-0.4638,0.2545-0.3820,0.1176-0.1639,3.4077-4.7064 mg·g^(-1),respectively.Conclusions The established fingerprint and content determination method was accurate and reliable,which can improve the quality standard of Xuemai Shutong granules,and provide reference

关 键 词：血脉疏通颗粒 超高效液相色谱-蒸发光散射检测器 指纹图谱 含量测定 

分 类 号：R286.0[医药卫生—中药学]