ICP-MS法测定鸦胆子油乳注射液和苦碟子注射液中的16种重金属及有害元素

Determination of 16 heavy metals and harmful elements residues in Yadanzi oil emulsion and Kudiezi injection

目的建立电感耦合等离子体质谱法(ICP-MS)测定鸦胆子油乳注射液及苦碟子注射液中16种重金属及有害元素(Pb、Cd、As、Hg、Co、V、Mo、Se、Cu、Cr、Al、B、Ni、Fe、Li、Ba)残留量的方法。方法样品经微波消解后,以Ge、In、Bi、Sc作为内标,采用ICP-MS法测定16种元素。结果各元素均呈良好的线性关系(r>0.9988),检出限为1~295 ng·L^(-1),加样回收率为92.1%~105.1%,RSD均<4.8%。Pb、Cd、As、Hg、Cu的残留量均符合规定,其他元素的安全性则需进一步研究。结论所用方法可方便有效地测定鸦胆子油乳注射液、苦碟子注射液中的重金属残留,同时,对中药注射剂中暂无规定限度的元素质量控制和探索研究提供了参考。

OBJECTIVE To detect heavy metals and harmful elements(Pb,Cd,As,Hg,Co,V,Mo,Se,Cu,Cr,Al,B,Ni,Fe,Li,Ba)in Yadanzi oil emulsion injection and Kudiezi injection using inductively coupled plasma mass spectrometry(ICP-MS).METHODS After samples were digested by microwave,16 elements were determined by ICP-MS,with Ge,In,Bi,and Sc as internal standards.RESULTS All elements showed good linear relationship(r>0.9988).The detection limit was 1-295 ng·L^(-1),the recovery rate of sample addition was 92.1%-105.1%,and the RSD was less than 4.8%.CONCLUSION Pb,Cd,As,Hg,and Cu are in compliance with the regulations,and the safety of other elements needs further research and discussion.This method can conveniently and effectively determine the heavy metal residues in Yadanzi oil emulsion injection and Kudiezi injection.At the same time,it can provide reference for quality control and exploratory research of elements in traditional Chinese medicine injections with no specified limits.