中国药物警戒 ›› 2023, Vol. 20 ›› Issue (10): 1108-1112.
DOI: 10.19803/j.1672-8629.20230235

• 基础与临床研究 • 上一篇    下一篇

基于多元素快速筛查西洋参中毒性元素的非致癌性与致癌性风险评估

左甜甜1, 王赵1,△, 郭愿生1,2, 魏锋1, 金红宇1,#, 马双成1,*   

  1. 1中国食品药品检定研究院,北京 100050;
    2中国药科大学,江苏 南京 211198
  • 收稿日期:2023-04-14 出版日期:2023-10-15 发布日期:2023-10-16
  • 通讯作者: *马双成,男,博士,研究员,中药质量控制。E-mail: masc@nifdc.org.cn。#为共同通信作者。
  • 作者简介:左甜甜,女,博士,副研究员,中药质量控制。△为并列第一作者。
  • 基金资助:
    国家重点研发计划（2022YFC3501500）

Non-carcinogenic and carcinogenic risk assessment of toxic elements in Panax quinquefolium L. based on multi-element semi-quantitative screening

ZUO Tiantian1, WANG Zhao1,△, GUO Yuansheng1,2, WEI Feng1, JIN Hongyu1,#, MA Shuangcheng1,*   

  1. 1National Institutes for Food and Drug Control, Beijing 100050, China;
    2China Pharmaceutical University, Nanjing Jiangsu 211198, China
  • Received:2023-04-14 Online:2023-10-15 Published:2023-10-16

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摘要： 目的 采用电感耦合等离子体质谱（ICP-MS）法对西洋参中多种重金属及毒性元素进行半定量快速筛查,并进行风险评估。方法 西洋参药材经微波消解前处理后,采用ICP-MS半定量测定方式,选择扫描全谱范围内所有元素,测定重金属及毒性元素。按照风险评估的基本步骤,对其中的Al、As、Cu、Pb、Mn、Ni、Cd的风险进行确定性评估。结果 西洋参中的 Pb、Cd、As、Hg、Cu的残留量均低于现行药典限定范围。多元素测定结果表明,西洋参中Fe、Mn的含量最高（含量范围分别为29.27~140.17 mg·kg-1和33.01~87.46 mg·kg-1）;Zn的含量其次（含量范围为8.27~22.72 mg·kg-1）;Se（含量≤0.43 mg·kg-1）、Sn的含量再次（含量范围为0.01~0.18 mg·kg-1）。风险评估结果表明,西洋参中重金属及毒性元素的日暴露量遵从规律Mn>Al>Cu>Ni>Cd>Pb>As。西洋参中Al、As、Cu、Pb、Mn、Ni、Cd的非致癌性风险可被接受,其中As和Pb的致癌性风险亦可被接受。结论 建立半定量分析方法与风险评估技术相结合,能够快速确定西洋参中有害目标元素的浓度范围及风险情况,为有效应对中药药害事故提供技术储备。

关键词: 西洋参, 重金属, 快速筛查, 中药多元素监测, 致癌性风险评估, 非致癌性风险评估

Abstract: Objective To semi-quantitative rapid screen and assess the risk of toxic elements in Panax quinquefolium L. by inductively coupled plasma mass spectrometry (ICP-MS). Methods After microwave digestion of Panax quinquefolium L., ICP-MS was used for semi-quantitative determination of heavy metals and toxic elements. According to the basic steps of risk assessment, the risks of Al, As, Cu, Pb, Mn, Ni and Cd were evaluated. Results The contents of Pb, Cd, As, Hg and Cu in Panax quinquefolium L. were lower than the limits of current Pharmacopoeia. The results of multi-elements showed that the contents of Fe and Mn were the highest (29.27~140.17 mg·kg-1 and 33.01~87.46 mg·kg-1）. The content of Zn was in the range of 8.27 to 22.72 mg·kg-1. The contents of Se were≤0.43 mg·kg-1. The content of Sn were 0.01~0.18 mg·kg-1. The results of risk assessment showed that the daily exposure of heavy metals and toxic elements in Panax quinquefolium L. was in the order: Mn > Al > Cu > Ni > Cd > Pb > As. The non-carcinogenic risk of Al, As, Cu, Pb, Mn, Ni and Cd can be accepted, and the carcinogenic risk of As and Pb can also be accepted. Conclusion The combination of semi-quantitative analysis method and risk assessment technology can quickly determine the concentration range and risk status of harmful target elements in Panax quinquefolium L., and provide scientific and technical support for effective response to accidents caused by TCMs.

Key words: Panax quinquefolium L., heavy metals, rapid analysis, multi element monitoring of traditional Chinese medicine, carcinogenic risk assessment, non-carcinogenic risk assessment

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