10种根和根茎类中药材中重金属及有害元素的风险评估及最大限量理论值  

Risk assessment and theoretical limits for heavy metals and harmful elements in 10 types of root and rhizome Chinese medicinal materials

作　　者：左甜甜 张磊 石上梅[3] 孙磊[1] 罗飞亚[1] 金红宇[1] 马双成[1] ZUO Tian-tian;ZHANG Lei;SHI Shang-mei;SUN Lei;LUO Fei-ya;JIN Hong-yu;MA Shuang-cheng(National Institutes for Food and Drug Control,Beijing 100050,China;China National Center for Food Safety Risk Assessment,Beijing 100022,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]国家食品安全风险评估中心,北京100022 [3]国家药典委员会,北京100061

出　　处：《药物分析杂志》2020年第10期1870-1876,共7页Chinese Journal of Pharmaceutical Analysis

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)。

摘　　要：目的:通过对10种根和根茎类中药材中重金属及有害元素的风险评估和最大限量理论值的计算,为相关残留限量标准的制修订提供参考依据。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川芎、当归、黄连、大黄、三七、巴戟天、人参、莪术、黄芩、党参总计883批10种根和根茎类中药材中重金属及有害元素的残留量进行测定和分析。同时,按照风险评估的基本步骤,并且系统地考虑人类平均寿命、中药使用频率、暴露年限、重金属及有害元素的转移率等参数,采用危害指数法(HI法)和暴露限值法(MOE法)对其重金属及有害元素的风险进行确定性评估,并计算其最大限量理论值。结果:883批根和根茎类中药材中整体合格率仅为57.76%。然而,风险评估的结果表明,除了巴戟天、莪术和黄连外,其他7个品种的风险可控。经过计算,得到根和根茎类药材中Pb、Cd、As、Hg、Cu的最大限量理论值分别为1.6、1.0、1.5、0.4和607 mg·kg-1。结论:本研究提出了符合中药使用特点的重金属及有害元素的风险评估模型和最大限量理论值的计算公式,为建立符合中药使用特点的风险评估技术体系,以及残留限量标准和相关指导原则的制修订提供技术支撑。Objective:To determine and analyze heavy metals and harmful elements in 10 root and rhizome Chinese medicinal materials,and to guide the formulation of their limit standard through risk assessment. Methods:Inductively coupled plasma mass spectrometry(ICP-MS) was used to determine and analyze the contents of heavy metals and harmful elements in 883 batches of Chuanxiong Rhizoma,Angelicae Sinensis Radix,Coptidis Rhizoma,Rhei Radix et Rhizoma,Notoginseng Radix et Rhizoma,Morindae Officinalis Radix,Ginseng Radix et Rhizoma,Curcumae Rhizoma,Scutellariae Radix and Codonopsis Radix collected nationwide.Moreover,according to the basic steps of risk assessment,the risks of heavy metals and harmful elements were assessed deterministically by the methods of hazardous index(HI) and margin of exposure(MOE),and the theoretical limits for heavy metals and harmful elements were calculated.The parameters including the average life span of human beings,the frequency of the usage of traditional Chinese medicines(TCMs),the exposure time,and the transfer rates of heavy metals and harmful elements were also taken into account in these two processes.Results:The overall qualified rate of 883 batches of root and rhizome varieties was only 57.76%.However,the results of risk assessment revealed that the risk of 7 varieties was acceptable except Morindae Officinalis Radix,Curcumae Rhizoma and Coptidis Rhizoma.The theoretical limits of lead,cadmium,arsenic,mercury and copper in root and rhizome varieties were 1.6,1.0,1.5,0.4 and 607 mg·kg-1,respectively.Conclusion:In the present study,a risk assessment model and the formula for calculating the theoretical limits for heavy metals and harmful elements are proposed,which conforms to the characteristics of TCMs.The study provides technical support for the establishment of risk assessment technical system applicable to the TCMs,the formulation of residue limit standards,and the revision of related guidelines.

关 键 词：中药材 根和根茎 重金属及有害元素 铅 镉 砷 汞 铜 风险评估 最大限量理论值 

分 类 号：R917[医药卫生—药物分析学]