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A novel approach to assessing quality issues and component annotation in TCM prescription: Insights from 100 common TCM products

文献类型：期刊论文

作者Ou, Huiting1,3; Liu, Chunxiang1,3; Ye, Saiyi1,3; Yang, Lin3; Bi, Qirui3; Wei, Wenlong3; Qu, Hua3; An, Yaling3; Zhang, Jianqing2,3; Guo, De-an1,2,3
刊名JOURNAL OF PHARMACEUTICAL ANALYSIS
出版日期2025-10-01
卷号15期号:10页码:12
关键词Traditional Chinese medicine prescription Quality consistency Automated annotation Large-scale products
ISSN号2095-1779
DOI10.1016/j.jpha.2025.101332
通讯作者Zhang, Jianqing(zhangjianqing@simm.ac.cn) ; Guo, De-an(daguo@simm.ac.cn)
英文摘要The quality of traditional Chinese medicine (TCM) prescriptions (TCMPs) is critical to clinical efficacy; however, evaluating their consistency and identifying sources of variability remain challenging. This study proposes an integrated strategy to assess the quality of 100 widely sold TCMPs. A "one-for-all" chromatographic method was employed to analyze 645 sample batches. This large-scale data collection enabled statistical evaluations, such as hierarchical cluster analysis (HCA) and similarity heatmap, to identify quality inconsistencies. The introduction of a TCM-specific mass spectrometry (MS) database allowed for rapid, automated annotation of chemicals across 100 prescriptions and facilitated the tracing of raw material sources. Results indicate that 19% of prescriptions exhibited chemical inconsistencies, which are associated with high market value, low pricing, and substantial price disparities. The MS database allowed rapid annotation of 761 and 673 compounds in positive and negative modes, respectively, in 100 TCMPs, with 73 prescriptions reported for the first time. The tracing efforts succeeded in identifying >40% of the raw material sources for 51 prescriptions. P93 (Yinianjin (YNJ)) is a case in which the chromatographic profiles from three manufacturers displayed inconsistencies. Analysis using the database traced divergent peaks to Rhei Radix et Rhizoma (RRER). Verification with self-prepared samples confirmed that manufacturers utilized three distinct botanical sources. This integrated strategy provides a scalable framework for quality control in TCMPs. (c) 2025 The Authors. Published by Elsevier B.V. on behalf of Xi'an Jiaotong University. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
资助项目Guangxi Science and Technology Major Project/Program, China[GUI-KEAA22096029] ; Guangxi Science and Technology Major Project/Program, China[GUIKEAA23023035] ; State Key Laboratory of Drug Regulatory Science Project, National Institutes for Food and Drug Control (NIFDC), China[2024SKLDRS0101] ; Shanghai Institute of Material Medical (SIMM)-National Engineering Research Center of TCM Standardization Technology Independent Research Program, China
WOS研究方向Pharmacology & Pharmacy
语种英语
WOS记录号WOS:001614611400001
出版者ELSEVIER
源URL[http://119.78.100.183/handle/2S10ELR8/321706]  
专题中国科学院上海药物研究所
通讯作者Zhang, Jianqing; Guo, De-an
作者单位1.Univ Chinese Acad Sci, Beijing 100049, Peoples R China
2.Shanghai Univ Tradit Chinese Med, Shanghai 201203, Peoples R China
3.Chinese Acad Sci, Shanghai Inst Mat Med, Natl Engn Res Ctr TCM Standardizat Technol, Shanghai 201203, Peoples R China
推荐引用方式
GB/T 7714		 Ou, Huiting,Liu, Chunxiang,Ye, Saiyi,et al. A novel approach to assessing quality issues and component annotation in TCM prescription: Insights from 100 common TCM products[J]. JOURNAL OF PHARMACEUTICAL ANALYSIS,2025,15(10):12.
APA Ou, Huiting.,Liu, Chunxiang.,Ye, Saiyi.,Yang, Lin.,Bi, Qirui.,...&Guo, De-an.(2025).A novel approach to assessing quality issues and component annotation in TCM prescription: Insights from 100 common TCM products.JOURNAL OF PHARMACEUTICAL ANALYSIS,15(10),12.
MLA Ou, Huiting,et al."A novel approach to assessing quality issues and component annotation in TCM prescription: Insights from 100 common TCM products".JOURNAL OF PHARMACEUTICAL ANALYSIS 15.10(2025):12.

入库方式： OAI收割

来源：上海药物研究所

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