Targeted trace ingredients coupled with chemometric analysis for consistency evaluation of Panax notoginseng saponins injectable formulations  

作　　者：ZHANG Jingxian ZHANG Zijia WANG Zhaojun ZHANG Tengqian ZHOU Yang CHEN Ming HUANG Zhanwen HE Qingqing LONG Huali HOU Jinjun WU Wanying GUO Dean 

机构地区：[1]National Engineering Research Center of TCM Standardization Technology,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai 201203,China [2]NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine,Shanghai Institute for Food and Drug Control,Shanghai 201203,China [3]Guangxi Key Laboratory of Comprehensive Utilization Technology of Pseudo-Ginseng,Guangxi Zhongheng Innovative Pharmaceutical Research Co.,Ltd.,Guangxi 530032,China [4]School of Pharmacy,University of Chinese Academy of Sciences,Beijing 100049,China

出　　处：《Chinese Journal of Natural Medicines》2023年第8期631-640,共10页中国天然药物（英文版）

基　　金：supported by the Science and Technology Service Network Initiative of the Chinese Academy of Sciences(STS,No.KFJ-STS-QYZD-2021-03-003);the Construction Projects of the Research Center for Notoginseng Health Products by the Department of Science and Technology of Guangxi Province(No.AD20297068);the Sanming Project of Medicine in Shenzhen(No.SZZYSM202106004).

摘　　要：Evaluating the consistency of herb injectable formulations could improve their product quality and clinical safety,particularly concerning the composition and content levels of trace ingredients.Panax notoginseng Saponins Injection(PNSI),widely used in China for treating acute cardiovascular diseases,contains low-abundance(10%-25%)and trace saponins in addition to its five main constituents(notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,and ginsenoside Rd).This study aimed to establish a robust analytical method and assess the variability in trace saponin levels within PNSI from different vendors and formulation types.To achieve this,a liquid chromatography-triple quadrupole mass spectrometry(LC-MS/MS)method employing multiple ions monitoring(MIM)was developed.A“post-column valve switching”strategy was implemented to eliminate highly abundant peaks(NR_(1),Rg_(1),and Re)at 26 min.A total of 51 saponins in PNSI were quantified or relatively quantified using 18 saponin standards,with digoxin as the internal standard.This study evaluated 119 batches of PNSI from seven vendors,revealing significant variability in trace saponin levels among different vendors and formulation types.These findings highlight the importance of consistent content in low-abundance and trace saponins to ensure product control and clinical safety.Standardization of these ingredients is crucial for maintaining the quality and effectiveness of PNSI in treating acute cardiovascular diseases.

关 键 词：Consistency evaluation Panax notoginseng saponins PCA analysis XUESHUANTONG XUESAITONG 

分 类 号：R917[医药卫生—药物分析学]