摘要
目的:建立测定复方氨基酸注射液(18AA)中14种金属元素含量的方法。方法:采用微波消解对样品进行前处理,使用电感耦合等离子体质谱法(ICP-MS)测定14种金属元素,内标法定量。结果:各元素在各自的检测质量浓度范围内线性关系良好(r≥0.9990);检测限为0.008~2.584 ng/mL;精密度试验的RSD为0.6%~3.5%;加样回收率为93.0%~104.1%(RSD为2.8%~6.9%,n=6)。结论:该方法操作简便、准确,精密度、重复性好,可用于测定复方氨基酸注射液(18AA)中多种金属元素的含量检测,为其风险监控提供参数。
Objective:To establish a method for the content determination of 14 metal elements in compound amino acid injection(18AA).Methods:After microwave digestion of the samples,14 metals were determined by inductively coupled plasma mass spectrometry(ICP-MS),using internal standard method for quantification.Results:The metal elements showed good linear relationship in a certain concentration ranges(r≥0.9990).The limits of detection were 0.008~2.584 ng/mL.RSDs of precision were 0.6%~3.5%.The recoveries were 93.0%~104.1%(RSD were 2.8%~6.9%,n=6).Conclusion:The method is simple,accurate,precise,reproducible and durable.It can be used for content determination of various metal elements in compound amino acid injection(18AA)and provide parameters for its risk monitoring.
作者
周敏
熊欣
程奇珍
ZHOU Min;XIONG Xin;CHENG Qizhen(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Quality Evalution of Traditional Chinese Patent Medicine,Jiangxi Provincial Engineering Research Center for Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)
出处
《药品评价》
CAS
2020年第17期14-16,26,共4页
Drug Evaluation
基金
江西省食品药品监督管理局科研项目(2017YX12)。
