基于ICP-MS法测定参苓白术丸中重金属多元素含量及其健康风险评估  

Analysis of Heavy Metal Elements in ShenLing BaiZhu Pills Based on ICP-MS and Health Risk Assessment

作　　者：严璐佳 胡敏 陈海滨 陈亮 陈在敏 YAN Lu-jia;HU Min;CHEN Hai-bin;CHEN Liang;CHEN Zai-min(Fujian Institute for Food and Drug Quality Control,Fuzhou 350000,China)

机构地区：[1]福建省食品药品质量检验研究院,福建福州350000

出　　处：《海峡药学》2024年第3期24-27,共4页Strait Pharmaceutical Journal

基　　金：福建省药品监督管理局科技计划项目(2022009)。

摘　　要：目的对参苓白术丸中五种重金属元素进行含量测定并对其评估健康风险。方法对36批参苓白术丸进行微波消解,基于ICP-MS法测定五种元素(Pb、Cd、As、Hg、Cu)的含量,结合理论限度值并采用靶标危害指数法对参苓白术丸中重金属及有害元素健康风险进行评估。结果各元素线性关系良好,且平均回收率在90.2%~101.0%之间,精密度和重复性的RSD值均小于3%。36批样品有5批Hg元素超标,均来自同一家企业,致使THQ值大于1。结论该方法准确稳定,重复性好,可用于参苓白术丸的质量控制,该健康风险评价模式可应用于参苓白术丸的风险评估。OBJECTIVE To analyze five heavy metal elements in ShenLing BaiZhu Pills and evaluate their health risks.METHODS Thirty six batches of ShenLing BaiZhu Pills were digested by microwave,and the contents of five elements(Pb,Cd,As,Hg,Cu)were determined by ICP-MS.The health risks of heavy metals and harmful elements in ShenLing BaiZhu Pills were assessed by target hazard index combined with theoretical limit values and health guidance values.RESULTS The linear relationship between the elements was good,and the average recovery rate was between 90.2%and 101.0%.The RSD values of precision and repeatability were both less than 3%.Out of 36 batches of samples,5 batches of Hg elements exceeded the standard,all from the same enterprise,resulting in THQ values greater than 1.CONCLUSION This method is accurate,stable,and has good repeatability,and can be used for quality control of ShenLing BaiZhu Pills.This health risk assessment model can be applied to risk assessment of ShenLing BaiZhu Pills.

关 键 词：参苓白术丸 重金属及有害元素 靶标危害 风险评估 限量标准 

分 类 号：R927[医药卫生—药学]