Novel assays for quality evaluation of XueBiJing:Quality variability of a Chinese herbal injection for sepsis management  

作　　者：Xuan Yu Wei Niu Ya-Ya Wang Olajide E.Olaleye Jia-Nan Wang Meng-Yuan Duan Jun-Ling Yang Rong-Rong He Zi-Xuan Chu Kai Dong Gui-Ping Zhang Chang-Xiao Liu Chen Cheng Chuan Li 

机构地区：[1]State Key Laboratory of Drug Research,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai,201203,China [2]School of Pharmacy,University of Chinese Academy of Sciences,Beijing,100049,China [3]Graduate School,Tianjin University of Traditional Chinese Medicine,Tianjin,300193,China [4]Research Institute,Tianjin Chasesun Pharmaceutical Co.,Ltd.,Tianjin,301700,China [5]State Key Laboratory of Drug Delivery Technology and Pharmacokinetics and Tianjin Key Laboratory of Quality-Marker of Traditional Chinese Medicines,Tianjin Institute of Pharmaceutical Research,Tianjin,300193,China

出　　处：《Journal of Pharmaceutical Analysis》2022年第4期664-682,共19页药物分析学报（英文版）

基　　金：funded by grants from the National Natural Science Foundation of China(Grant Nos.:82074176 and 81503345);Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine(Grant No.:ZYYCXTD-C-202009);the National Key R&D Program of China(Grant No.:2018YFC1704500).

摘　　要：XueBiJing is an intravenous five-herb injection used to treat sepsis in China.The study aimed to develop a liquid chromatography-tandem mass spectrometry(LC-MS/MS)-or liquid chromatography-ultraviolet(LC-UV)-based assay for quality evaluation of XueBiJing.Assay development involved identifying marker constituents to make the assay therapeutically relevant and building a reliable one-point calibrator for monitoring the various analytes in parallel.Nine marker constituents from the five herbs were selected based on XueBiJing's chemical composition,pharmacokinetics,and pharmacodynamics.A selectivity test(for“similarity of response”)was developed to identify and minimize interference by nontarget constituents.Then,an intercept test was developed to fulfill“linearity through zero”for each analyte(absolute ratio of intercept to C response,<2%).Using the newly developed assays,we analyzed samples from 33 batches of XueBiJing,manufactured over three years,and found small batch-to-batch variability in contents of the marker constituents(4.1%-14.8%),except for senkyunolide I(26.5%).

关 键 词：XUEBIJING Chinese herbal medicine Quality variability Quality marker One-point calibration 

分 类 号：R284[医药卫生—中药学]