牛黄解毒片中重金属及有害金属元素测定及健康风险评估  

Determination of Heavy and Deleterious Metallic Elements in Niuhuang Jiedu Tablets and Assessment of Health Risk

作　　者：李佳[1] 陈广云 熊金龙 张艳 卜媛媛[1] 陈小红[1] LI Jia;CHEN Guang-yun;XIONG Jin-long;ZHANG Yan;BU Yuan-yuan;CHEN Xiao-hong(Food and Drug Inspection Institute of Huaian,Huaian 223300,China)

机构地区：[1]江苏省淮安市食品药品检验所,江苏淮安223300

出　　处：《食品与药品》2024年第3期216-222,共7页Food and Drug

基　　金：江苏省市场监督管局科技计划项目(编号:KJ2022085)。

摘　　要：目的测定牛黄解毒片中重金属及有害金属元素残留情况,并将风险评估引入中药外源性污染评价。方法样品经微波消解后,采用ICP-MS法对60批牛黄解毒片中重金属及有害金属元素含量进行测定,按照危害识别、危害特征描述、暴露评估和风险描述的程序,对健康风险进行初步评估。结果所测得4种元素在各自范围内线性关系均良好(r≥0.997),回收率为87.3%~93.1%(RSD≤3.1%)。60批样品中Cu﹑Cd﹑Pb均未超标,Hg超标率为48.3%。结论该方法灵敏准确,考察了牛黄解毒片中重金属及有害元素残留情况,科学评估了重金属对人体的健康风险,为中药牛黄解毒片的安全性评价提供研究思路。Objective To determine the residual heavy metals and harmful metal elements in Niuhuang Jiedu Tablets and incorporate risk assessment into the evaluation of traditional Chinese medicine’s exogenous contamination.Methods After microwave digestion,the contents of heavy metals and harmful metal elements in 60 batches of Niuhuang Jiedu Tablets were determined using ICP-MS.The preliminary health risk assessment was conducted following the procedures of hazard identification,hazard characterization,exposure assessment and risk description.Results Linear relationships for the four elements within their respective ranges were excellent(r≥0.997),with recoveries ranging from 87.3%to 93.1%(RSDs≤3.1%).None of the 60 batches of samples exceeded the limits for Cd,Cu and Pb,while the content of Hg exceeded the limit in 48.3%of the samples.Conclusion This method is sensitive and accurate,which can be used for examination of the residual residual heavy metals and harmful metal elements in Niuhuang Jiedu Tablets and scientific assessment of the health risks of heavy metals to human body,thus can provide research ideas for the safety evaluation of Niuhuang Jiedu Tablets.

关 键 词：牛黄解毒片 ICP-MS 重金属 有害元素 健康风险评估 

分 类 号：R927.2[医药卫生—药学]