金莲清热颗粒指纹图谱建立及含量测定研究  

Research on Fingerprint Establishment and Content Determination of Jinlian Qingre Granules

作　　者：赵新芝[1] 王艺 李香 Zhao Xinzhi;Wang Yi;Li Xiang(Shandong Academy of Chinese Medicine,Jinan 250014,China;Shandong Provincial Maternal and Child Health Care Hospital Affiliated to Qingdao University,Jinan 250014,China;Shandong Public Health Clinical Center,Jinan 250100,China)

机构地区：[1]山东省中医药研究院,济南250014 [2]青岛大学附属山东省妇幼保健院,济南250014 [3]山东省公共卫生临床中心,济南250100

出　　处：《中国药事》2025年第4期461-470,共10页Chinese Pharmaceutical Affairs

基　　金：山东省中医药科技项目(编号2020Z09)。

摘　　要：目的:建立金莲清热颗粒指纹图谱和含量同时测定的分析方法,并采用高效液相色谱-四极杆飞行时间质谱联用(HPLC-Q TOF MS)技术定性分析金莲清热颗粒的主要化学成分,为其质量控制提供参考。方法:通过高效液相色谱(HPLC)法建立金莲清热颗粒的指纹图谱并同时进行含量测定,采用中药色谱指纹图谱相似度评价软件(2012年版)对20批金莲清热颗粒进行相似度评价,利用HPLC-Q TOF MS技术对共有峰进行化学成分分析鉴别。结果:建立了金莲清热颗粒指纹图谱,确定了59个共有峰,通过HPLC-Q TOF MS技术指认了其中35个共有峰成分,20批样品的相似度为0.976~0.994,牡荆苷和毛蕊花糖苷含量分别为0.462~0.718 mg·g^(-1)和0.104~0.287 mg·g^(-1)。结论:HPLC指纹图谱技术联合Q TOF MS定性鉴别,可为金莲清热颗粒的后续相关质量标准提升提供参考依据。Objective:To establish an analytical method for the simultaneous determination of fingerprints and contents of Jinlian Qingre Granules,and to qualitatively analyze the main chemical constituents of Jinlian Qingre Granules by HPLC-Q TOF MS,so as to provide references for quality control of Jinlian Qingre Granules.Methods:The fingerprints of Jinlian Qingre Granules and contents determination methods were established by HPLC.The“Similarity Evaluation System of Chromatographic Fingerprints of Traditional Chinese Medicine”(Version 2012) was used to evaluate the similarity of the HPLC fingerprints of 20 batches of Jinlian Qingre Granules.The chemical constituents of the common peaks in Jinlian Qingre Granules were analyzed and identify by HPLC-Q TOF MS.Results:The HPLC fingerprints of Jinlian Qingre Granules were established,and 59 common peaks were confirmed,in which 35 chemical constituents of the common peaks were identified by HPLC-Q TOF MS.The similarity of 20 batches of samples ranged from 0.976 to 0.994.The contents of vitexin and acteoside in each batch of samples were 0.462-0.718 mg·g~(-1) and 0.104-0.287 mg·g~(-1),respectively.Conclusion:HPLC fingerprints technology combined with qualitative identification of Q TOF MS can provide references for the quality standard improvement of Jinlian Qingre Granules.

关 键 词：金莲清热颗粒 高效液相色谱指纹图谱 含量测定 高效液相色谱-四极杆飞行时间质谱联用 

分 类 号：R917[医药卫生—药物分析学]