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

## TL;DR

This study evaluates the quality consistency of 100 common traditional Chinese medicine prescriptions using a new method that identifies chemical inconsistencies and traces raw material sources.

## Contribution

The study introduces a scalable framework for TCM quality control using a TCM-specific mass spectrometry database and large-scale data analysis.

## Key findings

- 19% of prescriptions showed chemical inconsistencies linked to price disparities.
- A TCM-specific MS database annotated 761 and 673 compounds in positive and negative modes.
- Raw material sources were traced for over 40% of 51 prescriptions.

## Abstract

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.

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•First large-scale quality consistency study on 100 TCM prescriptions (645 batches).•19% of prescriptions exhibited inconsistencies, associated with price disparities.•Simultaneous annotation of chemicals in 100 prescriptions, 73 newly reported.•Case study: TCM-PCDL for compound annotation and ingredient tracing.

First large-scale quality consistency study on 100 TCM prescriptions (645 batches).

19% of prescriptions exhibited inconsistencies, associated with price disparities.

Simultaneous annotation of chemicals in 100 prescriptions, 73 newly reported.

Case study: TCM-PCDL for compound annotation and ingredient tracing.