Huiting Ou, Chunxiang Liu, Saiyi Ye, Lin Yang, Qirui Bi, Wenlong Wei, Hua Qu, Yaling An, Jianqing Zhang, De-an Guo. A novel approach to assessing quality issues and component annotation in TCM prescription: Insights from 100 common TCM products[J]. Journal of Pharmaceutical Analysis. doi: 10.1016/j.jpha.2025.101332
Citation:
Huiting Ou, Chunxiang Liu, Saiyi Ye, Lin Yang, Qirui Bi, Wenlong Wei, Hua Qu, Yaling An, Jianqing Zhang, De-an Guo. A novel approach to assessing quality issues and component annotation in TCM prescription: Insights from 100 common TCM products[J]. Journal of Pharmaceutical Analysis. doi: 10.1016/j.jpha.2025.101332
Huiting Ou, Chunxiang Liu, Saiyi Ye, Lin Yang, Qirui Bi, Wenlong Wei, Hua Qu, Yaling An, Jianqing Zhang, De-an Guo. A novel approach to assessing quality issues and component annotation in TCM prescription: Insights from 100 common TCM products[J]. Journal of Pharmaceutical Analysis. doi: 10.1016/j.jpha.2025.101332
Citation:
Huiting Ou, Chunxiang Liu, Saiyi Ye, Lin Yang, Qirui Bi, Wenlong Wei, Hua Qu, Yaling An, Jianqing Zhang, De-an Guo. A novel approach to assessing quality issues and component annotation in TCM prescription: Insights from 100 common TCM products[J]. Journal of Pharmaceutical Analysis. doi: 10.1016/j.jpha.2025.101332
a. National Engineering Research Center of TCM Standardization Technology, Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, 201203, China;
b. University of Chinese Academy of Sciences, Beijing, 100049, China;
c. Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China
Funds:
The authors gratefully acknowledge the Guangxi Science and Technology Major Project/Program, China (Grant Nos.: GUIKEAA22096029 and GUIKEAA23023035), State Key Laboratory of Drug Regulatory Science Project, National Institutes for Food and Drug Control (NIFDC), China (Grant No.: 2024SKLDRS0101), and Shanghai Institute of Material Medical (SIMM)-National Engineering Research Center of TCM Standardization Technology Independent Research Program, China. We thank the staff members of the Large-scale Mass Spectrometry System at the National Facility for Protein Science in Shanghai (NFPS), Zhangjiang Lab, China for providing technical support. Fig. 4 and Graphical abstract were drawn by using BioGDP.com.
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) 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. 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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