监管技术

累积风险评估方法在5种植物类中药材中铅和镉联合暴露评估中的应用

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  • (1)中国食品药品检定研究院,北京 100050; (2)国家药典委员会,北京 100061; (3)湖北省药品监督检验研究院,武汉 430075; (4)河北省药品检验研究院,石家庄 050011; (5)国家食品安全风险评估中心,北京 100022

网络出版日期: 2021-11-09

Application of Cumulative Risk Assessment on Combined Exposure of Lead and Cadmium in 5 Types of Traditional Chinese Herbal Medicines

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  • (1)National Institutes for Food and Drug Control, Beijing 100050 , China; (2)ChinesePharmacopoeia Commission, Beijing 100061 , China; (3)Hubei Institute for Drug Control, Wuhan 430075 , China; (4)Hebei Institute for Drug Control, Shijiazhuang 050011 , China; (5)China National Center for Food Safety RiskAssessment, Beijing 100022 , China

Online published: 2021-11-09

摘要

目的:利用中药材中铅(Pb)和镉(Cd)的残留量数据,探索不同累积风险评估方法在评估中药外源性有害残留物联合暴露风险中的应用。方法:以5种植物类中药材中Pb和Cd的残留量专项监测数据为基础,计算暴露量。并通过文献检索,获得Pb和Cd的相关毒理学参数。根据分级评估的原则,分别采用危害指数(HI)法、靶器官毒性剂量(TTD)法和证据权重(WOE)法等3种累积风险评估方法,评估 5种植物类中药材中Pb和Cd联合暴露的健康风险。结果:HI法的评估结果表明,艾叶、车前草和黄连的 HI值大于1。TTD 法的评估结果表明,Pb和Cd的联合暴露对于神经系统和肾脏来说,艾叶、车前草、黄连、金银花的HI值>1;对于心血管和血液来说,艾叶、车前草、黄连的HI值>1。而 WOE法的评估结果则表明,Pb和Cd的联合暴露对于心血管、神经系统和睾丸来说,艾叶、车前草、黄连、金银花的HI值大于1;对于血液来说,艾叶的HI值大于1;对于肾脏来说,艾叶、车前草、黄连的HI值大于1。结论: 本研究首次建立了中药中铅和镉元素的分级别的累积评估模型。该评估模型的建立,为中药中重金属及有害元素的风险评估打开新的思路,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, 申明睿, 金红宇, 聂晶, 刘永利, 张磊, 李静, 石上梅, 马双成 . 累积风险评估方法在5种植物类中药材中铅和镉联合暴露评估中的应用[J]. 中国药事, 2020 , 34(9) : 1020 -1027 . DOI: 10.16153/j.1002-7777.2020.09.005

Abstract

Objective: To explore the application of different cumulative risk assessment methods in evaluating risk of combined exposure of exogenous harmful residues in traditional Chinese medicines (TCMs) based on the contents of lead (Pb) and cadmium (Cd) in TCMs. Method: Based on the monitoring data of lead and cadmium contents in 5 types of traditional Chinese herbal medicines, the exposure dosage was calculated. The toxicological parameters of lead and cadmium were obtained by literature review. According to the principle of grading assessment, three cumulative risk assessment methods, namely hazard index (HI), target organ toxicity dose (TTD) and weight of evidence (WOE), were used to assess the health risk of combined exposure of lead and cadmium in 5 types of traditional Chinese herbal medicines. Results: The results of HI method showed that the HI values for Artemisia argyi LevL et Vant., Plantago asiatica L., and Coptis chinensis Franch were greater than 1. The results of TTD method exhibited that for the combined exposure of Pb and Cd in the nervous system and kidney, the HI values of Artemisia argyi LevL et Vant., Plantago asiatica L., Coptis chinensis Franch and Lonicera japonica Thunb were more than 1. For the cardiovascular system and blood, the HI values of Artemisia argyi LevL et Vant., Plantago asiatica L., Coptis chinensis Franch were more than 1. The results of WOE method demonstrated that for cardiovascular system, nervous system, and testis, the HI values of Artemisia argyi LevL et Vant., Plantago asiatica L., Coptis chinensis Franch and Lonicera japonica Thunb were greater than 1. For blood, the HI value of Artemisia argyi LevL et Vant. was were greater than 1. For kidney, the HI values of Artemisia argyi LevL et Vant., Plantago asiatica L., and Coptis chinensis Franch were greater than 1. Conclusion: For the first time the study establishes the grading cumulative assessment models for the evaluation of Pb and Cd in TCMs. The established assessment model paves a new way for risk assessment of heavy metals and harmful elements in TCMs and provides technical support for formulating scientific limit standards.

参考文献

[1] National Research Council(NRC).Risk Assessment in the Federal Government:Managing the Process[S].1983.
[2] 张磊,李凤琴,刘兆平.食品中化学物累积风险评估方法及应用[J].中国食品卫生杂志,2011,23(4):378-382.
[3] World Health Organization.Food Consumption and Exposure Assessment of Chemicals:Report of FAO/WHO Consultation on Food Consumption and Exposure Assessment of Chemicals[S].1997.
[4] Food Standards Agency.Review of the Risk Assessment of Mixtures of Pesticides and Similar Substances:FSA/0691/0902.E231:E244 [S].2002.
[5] Health Council of the Netherlands.Pesticides in Food:Assessing the Risk to Children [S].2004.
[6] Environmental Protection Agency.Organophosphate Pesticides:Revised Cumulative Risk Assessment[S].2002.
[7] European Food Safety Authority.Cumulative Risk Assessment of Pesticides to Human Health:The Way Forward.European Food Safety Authority Scientific Colloquium 7,Summary Report[S].2007.
[8] 王绪卿,吴永宁,陈君石.食品污染监测低水平数据处理问题[J].中华预防医学杂志,2002,36(4):278-279.
[9] 中华人民共和国药典:一部[S].2015:249.
[10] 王彝白纳,刘爱东,李建文,等.11 省市成年居民中药消费状况调查[J].中国药事,2017,31(6):666-672.
[11] 潘兰,贾新岳,石明辉,等.6种药材中5种重金属转移率的测定[J].中成药,2017,39(6):1315.
[12] 甘彦雄,郑勇凤,汪蕾,等.基于ICP-MS分析蓬莪术醋制前后煎液及沉淀物重金属转移率变化[J].中国中药杂志,2016,41(1):65-69.
[13] 金力薇,赵灵佳,岳显可,等.十全大补膏及其组方药材重金属残留分析[J].实用药物与临,2017,20(11):1310-1314.
[14] 王国海,郭耀武,乔蓉霞,等.药材煎煮前后重金属及有害元素转移率的研究[J].安徽医药,2014,18(11):2072-2078.
[15] 左甜甜,张磊,金红宇,等.中药材提取前后重金属及有害元素转移率和分级别风险评估的研究[J].药物分析杂志,2017,37(8):1398-1405.
[16] 中华人民共和国药典:四部[S].2015:402-404.
[17] US.Environmental Protection Agency.Guidance on Cumulative Risk Assessment of Pesticide Chemicals that Have a Common Mechanism of Toxicity[S].1999.
[18] Summary Report of the Seventy-Third Meeting of JECFA:Joint FAO/WHO Expert Committee on Food Additives[EB/OL].(2010-06-24)[2019-06-09].http://www.who.int/foodsafety/publications/jecfa-reports/en/.
[19] Agency for Toxic Substances and Disease Registry.Guidance Manual for the Assessment of Joint Toxic Action of Chemical Mixtures[EB/OL].(2004-10-12)[2019-10-11].https://www.atsdr.cdc.gov/interactionprofiles/ip-ga/ipga.pdf.
[20] 隋海霞,王珊,杨大进,等.我国成人饮白酒者抗雄激素作用样邻苯二甲酸酯类物质的累积风险评估[J].中国食品卫生杂志,2015,27(4):451-455.
[21] SccS,Scenhi R,ScheR.Toxicity and Assessment of Chemical Mixtures[EB/OL].(2012-08-11)[2019-10-11].http://ec.europa.Eu/health/scientific_committees/environmental_risks/docs/scher_o_155.pdf.
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