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Comprehensive Quality Evaluation of ShuXueNing Injection Employing Quantitative High-Performance Liquid Chromatography Fingerprint and Chemometrics

Yu Zhang Xin Xu Hua‑Wen Qi Yu‑Cheng Liu Jia‑Tao Dong Gui‑Cai Xi Hong‑Li Jin Yan‑Fang Liu Xin‑Miao Liang

世界中医药杂志(英文版)2021,Vol.7Issue(1):54-62,9.
世界中医药杂志(英文版)2021,Vol.7Issue(1):54-62,9.DOI:10.4103/wjtcm.wjtcm_8_21

Comprehensive Quality Evaluation of ShuXueNing Injection Employing Quantitative High-Performance Liquid Chromatography Fingerprint and Chemometrics

Comprehensive Quality Evaluation of ShuXueNing Injection Employing Quantitative High?Performance Liquid Chromatography Fingerprint and Chemometrics

Yu Zhang 1Xin Xu 2Hua‑Wen Qi 2Yu‑Cheng Liu 3Jia‑Tao Dong 3Gui‑Cai Xi 3Hong‑Li Jin 1Yan‑Fang Liu 2Xin‑Miao Liang1

作者信息

  • 1. Chinese Medicine Science Center,Key Laboratory of Separation Science for Analytical Chemistry,Dalian Institute of Chemical Physics,Chinese Academy of Sciences,Dalian 116023
  • 2. TCM Standardization Technology Research Group,DICP?CMC Innovation Institute of Medicine,Taizhou 225300
  • 3. HeiLongJiang ZBD Pharmaceutical Co.,Ltd,Heilongjian,158400,China
  • 折叠

摘要

Abstract

Objective: In this study, a comprehensive and effective quality method for evaluating the efficacy of ShuXueNing injection (SXNI) was developed. Materials and Methods: Quantitative high?performance liquid chromatography fingerprint, the quantitative analysis of multicomponents by a single marker (QAMS) method, hierarchical cluster analysis (HCA) , and orthogonal partial least squares discrimination analysis (OPLS?DA) were used to distinguish 53 batches of SXNI samples from 7 manufacturers. Results: A total of 53 batches of samples were analyzed to establish antithesis fingerprint of SXNI, and 12 peaks of the common model were collected and used for the similarity analysis. Meanwhile, six index flavonoid components were determined by the QAMS method, using rutin as internal reference substance. The accuracy of the QAMS method was confirmed by investigating the relative deviation between the QAMS method and the traditional external standard method. The results demonstrated that there was no significant difference (RE < 1%), suggesting that QAMS was a reliable and convenient method for the content determination of multiple components. The HCA and OPLS?DA methods drew a similar conclusion. The 53 batches of SXNI samples from 7 manufacturers were categorized into five groups, indicating that chemometrics could reveal the quality differences of SXNI between the manufacturers. Conclusions: The method established herein was efficient and successful in assessing the quality of SXNI, and that it may be potentially employed in the quality control of related products composed of Ginkgo biloba extract.

关键词

Chemometrics/quantitative analysis of multicomponents by a single marker/quantitative high‑performance liquidchromatography fingerprint/ShuXueNing injection

Key words

Chemometrics/quantitative analysis of multicomponents by a single marker/quantitative high‑performance liquidchromatography fingerprint/ShuXueNing injection

引用本文复制引用

Yu Zhang,Xin Xu,Hua‑Wen Qi,Yu‑Cheng Liu,Jia‑Tao Dong,Gui‑Cai Xi,Hong‑Li Jin,Yan‑Fang Liu,Xin‑Miao Liang..Comprehensive Quality Evaluation of ShuXueNing Injection Employing Quantitative High-Performance Liquid Chromatography Fingerprint and Chemometrics[J].世界中医药杂志(英文版),2021,7(1):54-62,9.

基金项目

This work was supported financially by the Guangxi Science and Technology Research Project(GuiKeAA18242040)and the National Science and Technology Major Project(2018ZX09735?002). (GuiKeAA18242040)

世界中医药杂志(英文版)

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