ICP-AES法检测脂肪乳注射液中铝元素杂质的含量  

Determination of Aluminum Impurities in Fat Emulsion Injection by ICP-AES

作　　者：王震红 阚微娜 赵哲 杨宏伟 WANG Zhen-hong;KAN Wei-na;ZHAO Zhe;YANG Hong-wei(Liaoning Institute for Drug Control,Liaoning Shenyang 110036,China)

机构地区：[1]辽宁省药品检验检测院,辽宁沈阳110036

出　　处：《中国药物评价》2024年第4期286-288,共3页Chinese Journal of Drug Evaluation

基　　金：辽宁省检验检测认证中心创新创业项目《肠外营养液等大容量注射剂中杂质铝测定方法的建立及来源分析》(项目编号:SC20210115)。

摘　　要：目的:建立测定脂肪乳注射液中铝元素杂质含量的电感耦合等离子原子发射光谱(ICP-AES)法。方法:样品稀释后,采用电感耦合等离子原子发射光谱法进行测定,以标准曲线法计算铝元素含量。结果:铝元素在0~200μg·L^(-1)范围内线性关系良好(r=0.99993),重复性试验结果RSD为2.0%,方法检出限为1.22μg·L^(-1),方法定量限为4.07μg·L^(-1),加样回收率平均值为107.7%,RSD为2.7%(n=6)。结论:该方法操作简单、灵敏,准确度高、重现性好,适用于脂肪乳注射液中铝元素杂质含量的测定。Objective:To establish a ICP-AES method for the determination of aluminum impurities in fat emulsion injection.Methods:After the sample was diluted,ICP-AES method was used to determine the content of aluminum impurities in fat emulsion injection.The standard curve method was used to calculate aluminum content.Results:The linear range of aluminum was 0-200μg·L^(-1),and the correlation coefficient was 0.99993.The RSD of repetitive experiments was 2.0%.The detectiong limit of the method was 1.22μg·L^(-1).The quantitation limit of the method was 4.07μg·L^(-1).The average value of sample recovery rate was 107.7%with RSD of 2.7%(n=6).Conclusion:The method was convenient,sensitive,accurate and good repeatability,which can be used for the determination of aluminum impurities in fat emulsion injection.

关 键 词：电感耦合等离子体原子发射光谱 脂肪乳注射液 铝元素杂质 

分 类 号：R927.12[医药卫生—药学]