中国药物警戒 ›› 2026, Vol. 23 ›› Issue (8): 852-858.
DOI: 10.19803/j.1672-8629.20260074

• 基础与临床研究 • 上一篇    下一篇

山银花中铅、镉、砷污染评价及致癌性概率风险评估

廖畅1,2, 刘佳琳3,Δ, 左甜甜2, 林永强2, 程显隆2, 任娅婷4, 王燕燕4, 王艳楠4#, 孔德娟4,*   

  1. 1中国药科大学药物质量与安全预警教育部重点实验室,江苏 南京 210009;
    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;
    3天津市疾病预防控制中心,天津 300011;
    4通辽市市场检验检测中心,国家药品监督管理局中药蒙药质量控制重点实验室,内蒙古 通辽 028000
  • 收稿日期:2026-01-23 出版日期:2026-08-15 发布日期:2026-08-17
  • 通讯作者: *孔德娟,女,硕士,副主任药师,中药（蒙药）质量控制。E-mail: kongdejuan_1123@163.com#为共同通信作者。
  • 作者简介:廖畅,女,在读硕士,中药质量控制。Δ为并列第一作者。
  • 基金资助:
    国家自然科学基金资助项目（82504738）

Assessment of pollution and probabilistic carcinogenic risk of Pb, Cd and As in Lonicerae Flos

Liao Chang1,2, Liu Jialin3,Δ, Zuo Tiantian2, Lin Yongqiang2, Cheng Xianlong2, Ren Yating4, Wang Yanyan4, Wang Yannan4#, Kong Dejuan4,*   

  1. 1Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, Nanjing Jiangsu 210009, China;
    2National Institutes for Food and Drug Control, State Key Laboratory of Drug Regulatory Science, Beijing 102629, China;
    3Tianjin Center for Disease Control and Prevention, Tianjin 300011, China;
    4Tongliao Market Detection and Testing Center, NMPA Key Laboratory of Quality Control of Traditional Chinese Medicine and Mongolian Medicine, Tongliao Inner Mongolia 028000, China
  • Received:2026-01-23 Online:2026-08-15 Published:2026-08-17

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摘要： 目的 建立适应中药用药特征的重金属及有害元素污染评价与致癌性概率风险评估体系。方法 利用电感耦合等离子体质谱（ICP-MS）测定41批灰毡毛忍冬来源山银花中铅（Pb）、镉（Cd）和砷（As）的含量,采用单因子污染指数与尼梅罗综合指数进行污染评价。基于蒙特卡洛模拟,结合致癌风险（CR）模型,评估山银花中3种元素的致癌风险概率。结果 经转移率修正后的单因子污染指数范围分别为Pb 0.00~0.52、Cd 0.01~0.63、As 0.00~0.11,Cd为主要污染贡献因子。尼梅罗综合污染指数介于0.01~0.34,整体处于安全至轻度污染水平。致癌性概率风险评估提示,对于一般及高暴露人群,山银花中Cd与As所带来的致癌风险值得关注。结论 构建适用于灰毡毛忍冬来源山银花中重金属及有害元素的污染评价与致癌性概率风险评估综合方法,为中药安全性评价及相关限量标准制定提供参考。

关键词: 山银花, 铅, 镉, 砷, 重金属, 单因子污染指数法, 尼梅罗综合指数法, 蒙特卡洛模拟

Abstract: Objective To establish a framework for assessment of pollution by heavy metals and harmful elements and the probabilistic carcinogenic risk that is consistent with the usage of traditional Chinese medicine (TCM). Methods The contents of lead (Pb), cadmium (Cd), and arsenic (As) in 41 batches of Lonicerae Flos derived from Lonicera macranthoides were determined via inductively coupled plasma mass spectrometry (ICP-MS). Levels of contamination were assessed using the single-factor pollution index and the Nemerow comprehensive pollution index. The probabilistic carcinogenic risk was also studied based on Monte Carlo simulation combined with the carcinogenic risk (CR) model. Results After correction by the transfer rate, the single-factor pollution indices ranged from 0.00 to 0.52 for Pb, 0.01 to 0.63 for Cd, and 0.00 to 0.11 for As, with Cd being the primary contributing pollutant. The Nemerow comprehensive pollution index ranged from 0.01 to 0.34, indicating an overall pollution level from safe to slight contamination. The probabilistic carcinogenic risk assessment suggested that the carcinogenic risks attributable to Cd and As in Lonicerae Flos warranted attention in both general and high-exposure populations. Conclusion An integrated approach to assessment of contamination and probabilistic carcinogenic risk of heavy metals and harmful elements in Lonicerae Flos derived from Lonicera macranthoides has been established, which is expected to provide technical support for safety evaluation of TCM and for the formulation or revision of relevant regulatory limit standards.

Key words: Lonicerae Flos, Lead (Pb), Cadmium (Cd), Arsenic (As), Heavy Metals, Single Factor Pollution Index Method, Nemerow Comprehensive Index Method, Monte Carlo Simulation

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