Chinese Journal of Pharmacovigilance ›› 2026, Vol. 23 ›› Issue (9): 982-988.
DOI: 10.19803/j.1672-8629.20260518

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Probabilistic risk assessment of heavy metals and harmful elements in Korean red ginseng, American ginseng and licorice

Li Jing1, Liao Chang2, Zuo Tiantian2, Lin Yongqiang2, Huang Zhe1,*   

  1. 1School of Business Administration, Shenyang Pharmaceutical University, Shenyang Liaoning 110016, China;
    2National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China
  • Received:2026-06-29 Online:2026-09-15 Published:2026-09-15

Abstract: Objective To determine the levels of heavy metals and harmful elements in imported Korean red ginseng, American ginseng, and licorice, and to assess their potential health risks using a probabilistic risk assessment approach. Methods A total of 416 batches of Korean red ginseng, 93 batches of American ginseng, and 102 batches of licorice were collected. The concentrations of lead (Pb), cadmium (Cd), arsenic (As), and mercury (Hg) were determined using inductively coupled plasma mass spectrometry (ICP-MS). A Monte Carlo simulation model was constructed to estimate population exposure levels (chronic daily intake, CDI). The non-carcinogenic risk (hazard index, HI) and carcinogenic risk (total carcinogenic risk, TCR) were subsequently assessed, with particular attention to risk characteristics under high-exposure scenarios. Results The concentrations of Pb, Cd, As, and Hg in all these samples were below the maximum limits specified in the Chinese Pharmacopoeia (2025 edition), although differences were observed between the three herbal materials. The mean concentrations of Pb and As were relatively higher in licorice. Probabilistic risk assessment indicated that the HI remained below the safety threshold of 1 even at the P99 percentile for all the three herbal medicines. The calculated TCR were also below 10-4, suggesting an overall acceptable risk level. However, variations in the contribution of individual elements to the overall risk were observed among the herbs, with arsenic in licorice contributing relatively more to the risk among high-exposure populations. Conclusion Heavy metal contamination in imported Korean red ginseng, American ginseng, and licorice is generally low and within acceptable safety limits. Nevertheless, variations exist among these herbal materials in terms of high-exposure risk and element-specific contributions. Probabilistic risk assessment can reveal characteristics of risk distribution beyond traditional limit-based evaluations, providing useful evidence for identifying potentially higher-risk herbal materials and supporting differentiated quality control strategies for imported medicinal herbs.

Key words: Korean Red Ginseng, American Ginseng, Licorice, Imported Medicinal Herbs, Heavy Metals and Harmful Elements, Probabilistic Risk Assessment, Risk Characteristics

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