男宝胶囊中重金属及有害元素的残留量测定及风险评估

Determination and Risk Assessment of Heavy Metal and Harmful Element Residues in Nanbao Capsules

目的:研究男宝胶囊中重金属及有害元素的残留情况并进行风险评估。方法:采用微波消解-电感耦合等离子体质谱法,测定10个生产单位的80批样品中铅、镉、砷、汞、铜、钒、铬、钴、镍9种元素的残留量,并采用热图及多变异源图对测定结果进行差异性比较,同时对其进行健康风险评估。结果:9种元素线性关系良好,相关系数r≥0.9999,平均回收率在76.64%~102.49%,RSD为1.09%~6.92%(n=6)。80批次男宝胶囊样品中铅、镉、砷、汞、铜、钒、铬、钴、镍的残留量分别为0.384~2.887、0.060~0.289、0.213~13.904、0.002~35.412、2.250~10.382、0.302~1.676、0.348~5.388、0.187~0.878、1.608~4.962 mg·kg^(-1)。铬、砷、铅和汞4种元素的残留量存在一定的差异性,其中汞最为显著,分析差异主要是由生产单位原材料质量控制不稳定导致的;风险评估结果表明,有1批次样品的汞残留量高于最大限量理论值和中国香港中成药注册安全性技术指引中相关规定值,提示此批次样品存在一定的健康风险。结论:本研究可为男宝胶囊重金属及有害元素残留量测定提供参考依据以及为保证用药安全提供基础。

Objective:To inspect heavy metal and harmful element residues in Nanbao capsules for risk evaluation.Method:Microwave digestion-inductively coupled plasma mass spectrometry(ICP-MS)was established to determine the residues of Pb,Cd,As,Hg,Cu,V,Cr,Co and Ni in 80 batches of samples from 10 producers,heat map and multi-variation source map were used to compare the results,and then health risk assessment was conducted.Results:The linear relationships for the 9 elements were good,with correlation coefficients r≥0.9999.The recoveries were 76.64%-102.49%,and RSD were 1.09%-6.92%(n=6).The residues of Pb,Cd,As,Hg,Cu,V,Cr,Co and Ni in the 80 batches of Nanbao capsule samples were 0.384-2.887,0.060-0.289,0.213-13.904,0.002-35.412,2.250-10.382,0.302-1.676,0.348-5.388,0.187-0.878 and 1.608-4.962 mg·kg^(-1).The residual amounts of Cr,As,Pb and Hg varied in some extents,and Hg varied the most significantly.The analysis differences were mainly caused by unstable quality control of raw materials.The results of risk assessment showed that the residual Hg of one batch of the samples exceeded the maximum theoretical limit value and the relevant value specified in the safety technical guidelines for the registration of Chinese patent medicine in Hong Kong,suggesting that this batch of samples had certain health risks.Conclusion:This study can provide reference for the determination of heavy metal and harmful element residues in Nanbao capsules and provide basis for drug safety.