中国药物警戒 ›› 2026, Vol. 23 ›› Issue (9): 982-988.
DOI: 10.19803/j.1672-8629.20260518

• 基础与临床研究 • 上一篇    下一篇

高丽红参、西洋参及甘草中重金属与有害元素概率风险评估

李静1, 廖畅2, 左甜甜2, 林永强2, 黄哲1,*   

  1. 1沈阳药科大学工商管理学院,辽宁 沈阳 110016;
    2中国食品药品检定研究院药品监管科学全国重点实验室,北京 102629
  • 收稿日期:2026-06-29 出版日期:2026-09-15 发布日期:2026-09-15
  • 通讯作者: *黄哲,女,博士,教授·博导,药品监管科学。E-mail: huangzhe2000@sina.com
  • 作者简介:李静,女,本科,助理研究员,药品监管科学。
  • 基金资助:
    国家自然科学基金资助项目（82504738）; 国家重点研发计划（2023YFC3504102）; 药品监管科学全国重点实验室课题（2026SKLDRS03114）

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

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摘要： 目的 检测进口高丽红参、西洋参及甘草中重金属与有害元素残留水平,并基于概率风险评估方法分析其潜在风险特征。方法 收集进口高丽红参416批、西洋参93批和甘草102批,采用电感耦合等离子体质谱（ICP-MS）测定铅（Pb）、镉（Cd）、砷（As）和汞（Hg）的含量。构建蒙特卡罗模拟模型计算人群暴露量（CDI）,并进一步评估非致癌风险和致癌风险（TCR）,分析不同药材在高分位暴露情景下的风险特征。结果 3种药材中Pb、Cd、As、Hg含量均未超过《中华人民共和国药典》（2025年版）限量标准,但不同药材之间存在一定差异。甘草中Pb和As的平均含量相对较高。概率风险评估结果显示,3种药材中重金属的非致癌总危害指数（HI）在P99分位水平仍低于安全阈值1,TCR均低于10-4,总体风险处于可接受范围。不同药材在风险贡献结构方面存在差异,其中甘草中As对高暴露人群风险贡献相对较高。结论 当前进口高丽红参、西洋参和甘草中重金属污染总体处于较低水平,但不同药材在高暴露人群风险及风险贡献元素方面存在差异。概率风险评估能够揭示传统限量判定之外的风险分布特征,为识别潜在风险较高品种及优化进口药材质量监控提供参考。

关键词: 高丽红参, 西洋参, 甘草, 进口中药材, 重金属及有害元素, 概率风险评估, 风险特征

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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