Objective To establish an inductively coupled plasma mass spectrometry (ICP-MS) method for the simultaneous determination of five dangerous elements (As, Cd, Cu, Hg, and Pb) in Dahuoluo pills, and to systematically evaluate heavy metal residues and human exposure risks of preparations from different manufacturers combined with multi-model health risk assessment system.

Methods A total of 75 batches of Dahuoluo pills were pretreated by microwave digestion, and the contents of the five elements were determined by ICP-MS. Box plots combined with Kruskal‑Wallis tests were used to analyze the inter-manufacturer differences in elemental distribution. Spearman's rank correlation analysis was performed to explore the relationships between heavy metal contents and exposure indicators. Health risk assessment was comprehensively conducted using hazard index (HI), margin of exposure (MOE), estimated daily intake (EDI), target hazard quotient (THQ), and carcinogenic risk (CR) models.

Results Except for Cu, significant differences in heavy metal residues were observed among manufacturers (P < 0.05). Batches with extremely excessive levels of As and Pb were detected, with maximum concentrations of 22.800 mg/kg and 59.800 mg/kg, respectively, which far exceeded the limits specified in the Chinese Pharmacopoeia (2025 edition). Spearman correlation analysis confirmed that heavy metal contents were significantly correlated with EDI, THQ, and MOE indicators, verifying that higher residual levels correspond to greater exposure risks. As, Hg, and Pb were identified as the primary risk elements. Manufacturer D exhibited multi-element contamination across multiple batches, with the highest overall health risk.

Conclusion The established ICP-MS method is sensitive and accurate for the simultaneous determination of harmful elements in Dahuoluo pills. Serious heavy metal exceedances were observed in preparations from some manufacturers. These products may pose potential chronic health risks. It is suggested to improve the whole-process supervision system by strengthening screening at the raw material source and finished product testing to reduce heavy metal exposure risks.

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