标准研讨

基于靶器官毒性剂量法的板蓝根中镉和砷的联合暴露评估*

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  • 1.中国食品药品检定研究院,北京 102629;
    2.河北省药物警戒中心,石家庄 050090
第一作者 左甜甜 Tel:(010)53851453;E-mail:zuotiantian2011@163.com刘永利 Tel:(0311)67909955;E-mail:liuyongli2008@126.com
**马双成 Tel:(010)53852076;E-mail:masc@nifdc.org.cn
于健东 Tel:(010)67095452;E-mail:yujiandong@nifdc.org.cn

修回日期: 2024-03-26

  网络出版日期: 2024-06-20

基金资助

*国家药典委员会标准提高课题 (2023Z07);中国食品药品检定研究院关键技术基金 (GJJS-2022-7-1)

Risk assessment of combined exposure to cadmium and arsenic in Isatidis Radix based on target-organ toxicity dose modification of HI method*

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  • 1. National Institutes for Food and Drug Control,Beijing 102629, China;
    2. The Pharmacovigilance Center of Hebei, Shijiazhuang 050090, China

Revised date: 2024-03-26

  Online published: 2024-06-20

摘要

目的: 对板蓝根中镉(Cd)和砷(As)的残留量进行测定,探索靶器官毒性剂量法在评估中药中重金属及有害元素联合暴露风险中的应用。方法: 根据板蓝根中Cd和As的残留量监测数据,计算其暴露量。采用危害指数(HI)法对Cd和As联合暴露产生的健康风险进行初步筛查。进一步针对不同毒理学终点,采用靶器官毒性剂量(TTD)法,对Cd和As的累积风险进行更加精确的评估。结果: 29批板蓝根中Cd的合格率为100%,5批As的含量超过限量标准。HI法的初步评估结果表明,5批板蓝根中As的危害商(HQ)值高于1。TTD法评估结果表明,对于作用终点心血管、血液、神经系统,5批板蓝根的HI值>1,健康风险需要被关注。结论: 本研究探索了中药材板蓝根中Cd和As的累积风险评估方法,为中药中外源性有害残留物风险评估方法开发提供新的思路,为制定更加科学的限量标准提供技术支撑。

本文引用格式

左甜甜, 刘永利, 金红宇, 李海亮, 刘芫汐, 于健东, 马双成 . 基于靶器官毒性剂量法的板蓝根中镉和砷的联合暴露评估*[J]. 药物分析杂志, 2024 , 44(4) : 714 -720 . DOI: 10.16155/j.0254-1793.2024.04.18

Abstract

Objective: To determine the contents of Cd and As in Isatidis Radix and to explore the application of target-organ toxicity dose(TTD) modification of hazard index (HI) method in assessing the risk of combined exposure to heavy metals and harmful elements in traditional Chinese medicines (TCMs). Methods: According to the monitoring data of Cd and As in Isatidis Radix, the exposure doses were calculated. The health risk caused by combined exposure to Cd and As was preliminary screened by HI method. Moreover, a more accurate TTD method was used. Results: The qualified rates of Cd in 29 batches of Isatidis Radix were 100%. However, 5 batches of As contents exceeded the limit standard. The HQ values of As in 5 batches of Isatidis Radix were more than 1. The results of TTD method showed that for the end points of cardiovascular system, blood, nervous system, the HI values of 5 batches of Isatidis Radix were more than 1, and the health risk was not acceptable. Conclusion: The cumulative risk assessment of heavy metals in TCMs is proposed in this study, which offers novel ideas for the development of risk assessment methods of exogenous harmful residues in TCMs, and provides technical support for formulating scientific limit standards.

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