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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