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

作　　者：周远华[1] 夏学深 张立雯[1] 董顺玲[1] ZHOU Yuanhua;XIA Xueshen;ZHANG Liwen;DONG Shunling(Guangzhou Institute for Drug Control,Guangzhou 510160,China)

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国现代应用药学》2024年第19期2679-2685,共7页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立电感耦合等离子体质谱(inductively coupled plasma mass spectrometry,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[钒(V)、铬(Cr)、钴(Co)、镍(Ni)、铜(Cu)、砷(As)、硒(Se)、银(Ag)、镉(Cd)、钡(Ba)、汞(Hg)、铊(Tl)、铅(Pb)]的残留量;采用危害指数(hazard index,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2020年版的参考限度,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<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。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 2020 edition and the Pb residue in 1 sample was exceeded the prescribed limit of ICH Q3D.The HI 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.The evaluation results indicate that there have no significant health risk in the absorption process of children.

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 

分 类 号：R927.11[医药卫生—药学]