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

文献类型：期刊论文

作者Yu, Xuan5,6; Niu, Wei6; Wang, Ya-Ya4,6; Olaleye, Olajide E.6; Wang, Jia-Nan5,6; Duan, Meng-Yuan5,6; Yang, Jun-Ling6; He, Rong-Rong6; Chu, Zi-Xuan5,6; Dong, Kai
刊名JOURNAL OF PHARMACEUTICAL ANALYSIS
出版日期2022-08-01
卷号12期号:4页码:664-682
ISSN号2095-1779
关键词XueBiJing Chinese herbal medicine Quality variability Quality marker One -point calibration
DOI10.1016/j.jpha.2022.01.001
通讯作者Cheng, Chen(chengchen@simm.ac.cn) ; Li, Chuan(chli@simm.ac.cn)
英文摘要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 cali-brator 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 non -target 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%).(c) 2022 The Authors. Published by Elsevier B.V. on behalf of Xi'an Jiaotong University. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
WOS关键词ONE-POINT CALIBRATION ; HYDROXYSAFFLOR-YELLOW ; PROTOCATECHUIC ACID ; BIOACTIVE COMPOUNDS ; PAEONIA-LACTIFLORA ; ENDOTHELIAL-CELLS ; SYSTEMIC EXPOSURE ; SENKYUNOLIDE I ; FERULIC ACID ; PAEONIFLORIN
资助项目National Natural Sci-ence Foundation of China[82074176] ; National Natural Sci-ence Foundation of China[81503345] ; Innovation Team and Talents Cultivation Program of NationalAdministration of Traditional Chinese Medicine[ZYYCXTD-C-2020 09] ; National Key R&D Program of China[2018YFC1704500]
WOS研究方向Pharmacology & Pharmacy
语种英语
出版者ELSEVIER
WOS记录号WOS:000862894700015
源URL[http://119.78.100.183/handle/2S10ELR8/302634]  
专题新药研究国家重点实验室
通讯作者Cheng, Chen; Li, Chuan
作者单位1.Tianjin Inst Pharmaceut Res, Tianjin Key Lab Qual Marker Tradit Chinese Med, Tianjin 300193, Peoples R China
2.Tianjin Inst Pharmaceut Res, State Key Lab Drug Delivery Technol & Pharmacokine, Tianjin 300193, Peoples R China
3.Tianjin Chasesun Pharmaceut Co Ltd, Res Inst, Tianjin 301700, Peoples R China
4.Tianjin Univ Tradit Chinese Med, Grad Sch, Tianjin 300193, Peoples R China
5.Univ Chinese Acad Sci, Sch Pharm, Beijing 100049, Peoples R China
6.Chinese Acad Sci, Shanghai Inst Mat Med, State Key Lab Drug Res, Shanghai 201203, Peoples R China
推荐引用方式
GB/T 7714		 Yu, Xuan,Niu, Wei,Wang, Ya-Ya,et al. Novel assays for quality evaluation of XueBiJing: Quality variability of a Chinese herbal injection for sepsis management[J]. JOURNAL OF PHARMACEUTICAL ANALYSIS,2022,12(4):664-682.
APA Yu, Xuan.,Niu, Wei.,Wang, Ya-Ya.,Olaleye, Olajide E..,Wang, Jia-Nan.,...&Li, Chuan.(2022).Novel assays for quality evaluation of XueBiJing: Quality variability of a Chinese herbal injection for sepsis management.JOURNAL OF PHARMACEUTICAL ANALYSIS,12(4),664-682.
MLA Yu, Xuan,et al."Novel assays for quality evaluation of XueBiJing: Quality variability of a Chinese herbal injection for sepsis management".JOURNAL OF PHARMACEUTICAL ANALYSIS 12.4(2022):664-682.

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来源：上海药物研究所

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