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

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,respec-tively,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.

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作者 Huiting Ou [1] Chunxiang Liu [1] Saiyi Ye [1] Lin Yang [2] Qirui Bi [2] Wenlong Wei [2] Hua Qu [2] Yaling An [2] Jianqing Zhang [3] De-an Guo [4] 学术成果认领
作者单位 National Engineering Research Center of TCM Standardization Technology,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai,201203,China;University of Chinese Academy of Sciences,Beijing,100049,China [1] National Engineering Research Center of TCM Standardization Technology,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai,201203,China [2] National Engineering Research Center of TCM Standardization Technology,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai,201203,China;Shanghai University of Traditional Chinese Medicine,Shanghai,201203,China [3] National Engineering Research Center of TCM Standardization Technology,Shanghai Institute of Materia Medica,Chinese Academy of Sciences,Shanghai,201203,China;University of Chinese Academy of Sciences,Beijing,100049,China;Shanghai University of Traditional Chinese Medicine,Shanghai,201203,China [4]
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DOI 10.1016/j.jpha.2025.101332
发布时间 2026-01-27(万方平台首次上网日期,不代表论文的发表时间)
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药物分析学报(英文版)

药物分析学报(英文版)

2025年15卷10期

2430-2441页

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