微波消解-ICP-OES法测定塑料输液容器中13种元素杂质  

Determination of 13 elemental impurities in plastic infusion containers by microwave digestione with ICP-OES

作　　者：罗洁 刘园园 颜敏 艾俊涛 刘磅 刘雁鸣 Luo Jie;Liu Yuanyuan;Yan Min;Ai Juntao;Liu Pang;Liu Yanming(Hunan Institute for Drug Control,Hunan Changsha 410000,China;Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Hunan Changsha 410000,China;Hunan Drug Inspection Center,Hunan Changsha 410000,China)

机构地区：[1]湖南省药品检验检测研究院,长沙410000 [2]湖南省药品质量评价工程技术研究中心,长沙410000 [3]湖南省药品审核查验中心,长沙410000

出　　处：《分析仪器》2025年第1期20-25,共6页Analytical Instrumentation

摘　　要：目的:建立一种检测准确、灵敏度高的能同时测定塑料输液容器中等13种元素杂质含量的分析方法,为塑料输液容器中元素杂质进行有效控制及安全性能评价提供技术支撑。方法:样品选择6mL硝酸+2mL过氧化氢体系微波消解,采用电感耦合等离子体发射光谱法(ICP-OES)测定消解液中13种元素杂质浓度。结果:13种元素杂质在相应的测定范围内呈良好的线性关系,相关系数r为0.99932~0.99995;回收率为75.39%~124.74%,RSD为0.66%~7.20%;方法检出限为0.02μg/g~4.03μg/g。经检测,20批样品,均未检出Mo、Sn元素;V、Co、Ni、Cu、Cd、Pb元素的含量很低,结果为未检出或低于定量限居多;Cr和Ba元素均有检出,Ti元素含量较高。Mg、Al两种元素含量最高。结论:该方法简便、准确、灵敏度高,可用于同时测定塑料输液容器中Al等13种元素杂质含量。The method provides technical support for effective control and safety evaluation of elemental impurities in plastic infusion containers.The samples were digested with 6ml nitric acid and 2ml hydrogen peroxide by microwave,and the concentrations of 13 metal elements in digestive solution were determined by ICP-OES.The 13 impurities showed a good linear relationship in the corresponding determination range,and the correlation coefficient was between 0.99932 and 0.99995.The recoveries were 75.39%-124.74%,RSD was 0.66%-7.20%The detection limit was 0.02μg/g-4.03μg/g.The results showed that Mo and Sn were not detected in all 20 samples,and the contents of V,Co,Ni,Cu,Cd and Pb were very low,the content of Ti was high.The contents of Mg and Al were the highest.This method is simple,accurate and sensitive.

关 键 词：微波消解 电感耦合等离子体发射光谱 塑料输液容器 金属杂质 

分 类 号：R28[医药卫生—中药学]