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抗栓胶囊中9种重金属有害元素的含量测定及风险评估 被引量:4

Determination and Risk Assessment of 9 Heavy Metal Elements in Kangshuang Capsules
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摘要 目的:测定抗栓胶囊中重金属有害元素的含量,对有害元素进行潜在的健康风险评估。方法:微波消解对样品进行前处理后,使用电感耦合等离子体质谱仪(ICP-MS)测定钒(V)、铬(Cr)、钴(Co)、镍(Ni)、铜(Cu)、砷(As)、镉(Cd)、汞(Hg)、铅(Pb)9种元素的含量。采用元素指纹图谱和热图对测定结果进行直观分析;使用风险评估模型评估9种有害元素的健康风险。结果:9种元素线性关系良好,r≥0.9990;回收率为78.81%~104.52%,平均回收率为80.87%~102.83%,RSD为0.72%~3.30%(n=6)。测定了9种重金属有害元素的含量,绘制的元素指纹图谱具有一定的特征性,热图表明,样品间Pb、Cr、Hg、As 4种元素的含量差异明显,Pb、As残留量较高,可能存有一定的潜在健康风险。结论:通过探究抗栓胶囊中的重金属有害元素,为该药的质量控制和安全性评价提供参考。 Objective:To establish a method for determination of heavy metals in Kangshuang capsules by Inductively Coupled Plasma Mass Spectrometry(ICP-MS)and evaluate the potential health risk of this drug.Method:Samples were pretreated by microwave digestion.ICP-MS was used to detect V,Cr,Co,Ni,Cu,As,Cd,Hg and Pb in the samples.The fingerprints of inorganic elements and heat map were used to statistical analysis of the elements.Results:All 9 elements showed good linearities in the selected concentration ranges(r≥0.9990).The recovers of the elements ranged 78.81%-104.52%,and the RSDs were 0.72%-3.30%(n=6).The contents of the 9 harmful elements in Kangshuan capsules were determined,and it was found that the element fingerprints had certain characteristics.The heat map shows that there were significant differences in the contents of Pb,Cr,Hg and As among the samples.The residual amounts of Pb and As in the samples were higher,which may have some potential health risks.Conclusion:Investigating the contents of harmful elements in Kangshuang capsules provides the basis for quality control and safety evaluation.
作者 薛平 陈雨蕉 胡金云 李莉 XUE Ping;CHEN Yujiao;HU Jinyun;LI Li(Changzhou Institute for Food,Drug and Fiber Control,Changzhou 213000,China)
出处 《药学与临床研究》 2022年第3期241-245,共5页 Pharmaceutical and Clinical Research
基金 国家药品监督管理局2021年国家药品抽验计划(序号7)。
关键词 抗栓胶囊 重金属有害元素 电感耦合等离子体质谱法 元素指纹图谱 热图 Kangshuang capsule Heavy metal and harmful elements ICP-MS Elemental fingerprint Heat map
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