七制香附丸中无机元素的分析及健康风险评估  

Analysis and health risk assessment of inorganic elements in Qizhi Xiangfu Pills

作　　者：李俊霖 沈沅 卞如玉 代磊 何丹[1] LI Jun-lin;SHEN Yuan;BIAN Ru-yu;DAI Lei;HE Dan(College of Pharmacy,Chongqing Medical University,Chongqing 400016,China)

机构地区：[1]重庆医科大学药学院,重庆400016

出　　处：《中国医院药学杂志》2023年第2期175-180,200,共7页Chinese Journal of Hospital Pharmacy

摘　　要：目的:建立电感耦合等离子体质谱(inductive coupled plasma mass spectrometer, ICP-MS)测定七制香附丸中23种无机元素含量的方法,并对分析结果进行化学计量学分析,为七制香附丸中无机元素的评价提供参考。方法:30批样品经微波消解后,采用ICP-MS测定23种无机元素的含量并建立无机元素指纹图谱,进行聚类分析、主成分分析和健康风险评估。结果:23种无机元素线性关系良好(r≥0.998 3);精密度和重复性试验的RSD值均小于5%;加样回收率在81.91%~109.4%,RSD值小于13%;对30批七制香附丸和23种无机元素进行层级聚类,30批七制香附丸分为3类,23种无机元素分为2类;主成分分析中Mg、Ca、Cr、Fe、Ni、Zn、As、Se、Cd、Tl元素经旋转后均大于0.8;健康风险评估结果显示Cu、As、Cd、Pb元素的危害指数(HI)分别为0.004 9,0.046 7,0.047 7,0.276 5,HI均小于1。结论:所建立的ICP-MS方法准确、灵敏、快速,可用于七制香附丸中23种无机元素的含量测定,30批次七制香附丸中Cu、As、Cd、Pb元素的健康风险较低。OBJECTIVE To establish ainductive coupled plasma mass spectrometer method for the content determination of 23 inorganic elements in Qizhi Xiangfu Pills.The results were analyzed by chemometrics methods, providing a reference for evaluating inorganic elements in QizhiXiangfu pills.METHODS The contents of 23 inorganic elements in 30 batchesof samples processed by microwave digestion were determined by ICP-MS.Moreover, the fingerprint of 23 inorganic elements was established, and the results were analyzed by hierarchical cluster analysis, principal component analysis, and risk assessment.RESULTS 23 inorganic elements were well within their respective linear relationship(r≥0.998 3);the RSDs of precision and repeatability were less than 5%;the recoveries of 23 inorganic elements were in the range of 81.91%-109.4%,and the RSDs were less than 13%;the results of hierarchicalcluster analysis showed that 30 batches of Qizhi Xiangfu Pills were divided into 3categories and 23 inorganic elements were divided into 2 groups;Mg, Ca, Cr, Fe, Ni, Zn, As, Se, Cd and Tl were all greater than 0.8 after rotation in principal component analysis;hazard indexes of Cu, As, Cd, Pbwere 0.004 9,0.046 7,0.047 7 and 0.276 5,respectively, and all of which were less than 1.CONCLUSION The established ICP-MS method was accurate, sensitive, and rapid, and it could be used for the determination of 23 inorganic elements in Qizhi Xiangfu Pills.The health risk of Cu, As, Cd, and Pb elements in 30 batches of QizhiXiangfu Pills was low.

关 键 词：七制香附丸 ICP-MS 无机元素 聚类分析 主成分分析 健康风险评估 

分 类 号：R917[医药卫生—药物分析学]