药食同源品种中重金属及有害元素的风险评估
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  • 英文篇名:Risk Assessment of the Heavy Metals and Harmful Elements in Medicine and Food Homologous Varieties
  • 作者:左甜甜 ; 金红宇 ; 屈浩然 ; 张磊 ; 孙磊 ; 李静 ; 马双成
  • 英文作者:ZUO Tiantian;JIN Hongyu;QU Haoran;ZHANG Lei;SUN Lei;LI Jing;Ma Shuangcheng;National Institutes for Food and Drug Control;Beijing University of Chinese Medicine;China National Center for Food Safety Risk Assessment;
  • 关键词:中药材 ; 药食同源 ; 重金属元素 ; 有害元素 ; 风险评估 ; 最大限量理论值 ; 质量控制 ; 中国药典
  • 英文关键词:Chinese medicinal herbs;;medicine and food homologous homology;;heavy metals;;harmful elements;;risk assessment;;maximum theoretical limit;;quality control;;Chinese Pharmacopoeia
  • 中文刊名:YYGZ
  • 英文刊名:China Pharmaceuticals
  • 机构:中国食品药品检定研究院;北京中医药大学;国家食品安全风险评估中心;
  • 出版日期:2019-05-05
  • 出版单位:中国药业
  • 年:2019
  • 期:v.28;No.484
  • 基金:国家药典委员会药品医疗器械审评审批制度改革项目[ZG2016-1]
  • 语种:中文;
  • 页:YYGZ201909010
  • 页数:4
  • CN:09
  • ISSN:50-1054/R
  • 分类号:37-40
摘要
目的测定9种药食同源品种中重金属及有害元素,通过风险评估制订其限量。方法采用电感耦合等离子体质谱(ICP-MS)法对全国范围内收集到的鱼腥草等299批9种药食同源品种中重金属及有害元素的残留量进行测定和分析,按照风险评估的基本步骤,对其重金属及有害元素的风险进行确定性评估,并计算其重金属及有害元素的最大限量理论值。结果 299批药食同源品种中,整体合格率为75. 25%;其中,枸杞子、木瓜、酸枣仁、玉竹和乌梢蛇全部合格,菊花、肉桂、鱼腥草和山银花合格率分别为91. 12%,46. 23%,15. 02%和9. 74%;除了鱼腥草外,其他8个药食同源品种风险可控,鱼腥草作为膳食的健康风险需要被关注;最大限量理论值的计算结果表明,2015年版《中国药典》中枸杞子铅和砷的限量大于其最大限量理论值,食品国标GB2762-2017中菊花和山银花中铅的限量大于最大限量理论值,其余限量合理。结论该方法可用于药食同源品种中重金属及有害元素的风险评估,建议以风险评估为指导,建立适用于药食同源品种使用特点的残留限量标准。
        Objective To determine the heavy metals and harmful elements in 9 types of medicine and food homologous varieties,and to guide the formulation of their limits by risk assessment. Methods Inductively coupled plasma-mass spectrometry( ICP-MS) was used to determine and analyze the residues of heavy metals and harmful elements in 299 batches of 9 types of medicine and food homologous varieties such as Houttuynia cordata collected nationwide. At the same time,according to the basic steps of risk assessment,the risks of heavy metals and harmful elements were assessed deterministically,and the maximum theoretical limits of heavy metals and harmful elements were calculated. Results The qualified rate of the 299 batches of medicine and food homologous varieties was75. 25%,among them,the qualified rate of Lycii Fructus,Fructus Chaenomelis,Ziziphi Spinosae Semen,Polygonati Odorati Rhizoma,and Zaocys was 100. 00%,the qualified rates of Chrysanthemi Flos,Cinnamomi Cortex,Houttuyniae Herba and Lonicerae Flos were91. 12%,46. 23%,15. 02% and 9. 74%,respectively. The results of risk assessment showed that except Houttuynia cordata,the risks of other 8 types of medicine and food homologous varieties were controllable. The health risk of Houttuynia cordata was needed to be concerned when used as food. The results of the maximum theoretical limits showed that the limits of lead and arsenic for Lycii Fructus in the Chinese Pharmacopoeia( 2015 edition) were higher than the maximum theoretical limits. And the limits of lead for Chrysanthemi Flos and Lonicerae Flos in national food standard GB2762-2017 were higher than the maximum theoretical limits,the rest of heavy metal and harmful element limits were reasonable. Conclusion This method can be used for risk assessment of heavy metals and harmful elements in medicine and food homologous varieties. It is suggested that the residue limit standard suitable for the use characteristics of medicine and food homologous varieties should be established with the guidance of risk assessment.
引文
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