基于ICP-MS的儿科常用中药口服液体制剂的重金属及有害元素残留量测定及其风险评估

Determination and risk assessment of heavy metals and harmful elements residues in pediatric oral liquid preparations of traditional Chinese medicine based on ICP-MS

关键词:  儿科  中药口服液体制剂  电感耦合等离子体质谱  重金属  有害元素  残留量  风险评估

Key words:  paediatrics  oral liquid preparations of traditional Chinese medicine  ICP-MS  heavy metals  harmful elements  residues  risk assessment

摘要:

目的 建立电感耦合等离子体质谱(ICP-MS)法筛查测定儿科常用中药口服液体制剂中重金属及有害元素的残留量,并进行风险评估。方法 43种共54批样品经微波消解后,采用半定量法进行全元素的扫描和浓度预估,采用定量分析方法同时测定样品中13种重金属及有害元素(V、Cr、Co、Ni、Cu、As、Se、Ag、Cd、Ba、Hg、Tl、Pb)的残留量；采用危害指数(HI)对5种重金属及有害元素(Hg、Pb、As、Cd、Cu)进行风险评估。结果 2批样品的Hg残留量超过中国药典的参考限度,1批样品的Pb残留量超过ICH Q3D的参考限度,全部样品中5种重金属及有害元素的HI均小于1。结论 所建方法能准确、高效测定儿科常用中药口服液体制剂中重金属及有害元素的残留量,评估结果表明儿童服用吸收过程中无重大健康风险。

Abstract:

Objective To establish a semi-quantitative and a quantitative method for screening determination of heavy metals and harmful elements residues in pediatric oral liquid preparations of traditional Chinese medicine by inductively coupled plasma mass spectrometry(ICP-MS), and to carry out the risk assessment. Methods After microwave digestion treatment of 43 species with 54 samples, the semi-quantitative method was used to scan and estimate the concentration of all elements, and then the quantitative method was established for the simultaneous determination of 13 heavy metals and harmful elements(V, Cr, Co, Ni, Cu, As, Se, Ag, Cd, Ba, Hg, Tl, Pb). Hazard index(HI) was used to carry out the risk assessment of 5 heavy metals and harmful elements(Hg, Pb, As, Cd, Cu). Results The Hg residues in 2 samples were exceeded the prescribed limit of Chinese pharmacopoeia and the Pb residue in 1 sample was exceeded the prescribed limit of ICH Q3D. The hazard indexes of 5 heavy metals and harmful elements in all samples were less than 1. Conclusion The proposed method is accurate and efficient. It can be used for the determination of heavy metals and harmful elements residues in common pediatric oral liquid preparations of traditional Chinese medicine. There have no significant health risk in the absorption process of children body.