黄金中杂质元素的检测及健康风险评估
Detection of Impurity Elements in Gold and Health Risk Assessment
柯浩奇 1王书晗 1向有缘 1彭俊1
作者信息
- 1. 深圳市药品检验研究院(深圳市医疗器械检测中心),广东 深圳 518052
- 折叠
摘要
黄金大量应用于医疗器械领域,为研究其潜在风险,采用电感耦合等离子体质谱法(ICP-MS)快速测定黄金显影点中 23 种杂质元素并对其进行健康风险评估.通过标准加入校正-内标法补偿基体效应,并通过方法学验证其检测结果的可靠性,确保测试结果的准确性和稳定性.研究结果表明,各待测杂质元素的校准曲线线性关系满足测试要求,方法检出限为0.021～0.705 μg/L,方法精密度(RSD,n=9)均小于5.0%,除砷和硒的回收率偏低,样品的回收率均在90.505%～105.750%范围内.该方法具有低检出限、高灵敏度、精密度良好,准确性高等特点,展现了 ICP-MS 法研究多元素含量的快速性、稳定性和优越性,同时,研究各杂质元素的可耐受接触TE值,将为黄金中杂质元素的健康风险评估工作提供重要的参考意义.
Abstract
Gold was widely used in medical devices.To study the risk of using,Inductively coupled plasma-mass spectrometry(ICP-MS)was used to quickly determine 23 impurity elements in the gold radiopaque marker and conduct health risk assessment.The matrix effect is compensated by the internal standard-addition correction method,and methodological verification is carried out to ensure the accuracy and stability of the test results.The results show that the linear relationship of the calibration curve of each impurity element to be tested meets the test requirements,the detection limit of the method is 0.021～0.705 μg/L,the method precision(RSD,n=9)is less than 5.0%,and the sample recovery rate is all within the range of 90.505%to 105.750%except the low recovery rate of As and Se.The method has the characteristics of low inspection limits,high sensitivity,good precision,high accuracy,showing the rapidness,stability and superiority of the ICP-MS method to study the variety of elements.And by calculating the tolerable exposure TE of each impurities element,it will provide important reference significance for the health risk assessment of impurity elements in gold.
关键词
黄金/显影点/杂质元素/电感耦合等离子体质谱法/健康风险评估Key words
gold/radiopaque marker/impurity elements/inductively coupled plasma-mass spectrometry/health risk assessment引用本文复制引用
基金项目
高风险医疗器械可沥滤物研究及标准化科技创新团队项目(2021TDB29)
血液接触类医疗器械/材料涂层牢固度评价方法研究科技创新团队项目(2022TDB52)
出版年
2024
NETL
NSTL
万方数据