广东化工2024,Vol.51Issue(16) :171-174,151.DOI:10.3969/j.issn.1007-1865.2024.016.054

ICP-MS法测定脂肪乳注射液中铝含量及其质量评价

Determination of Aluminum in Fat Emulsion Injection by ICP-MS and Quality Evaluation

何淑欣 吴娜 杨承勇 薛巧如
广东化工2024,Vol.51Issue(16) :171-174,151.DOI:10.3969/j.issn.1007-1865.2024.016.054

ICP-MS法测定脂肪乳注射液中铝含量及其质量评价

Determination of Aluminum in Fat Emulsion Injection by ICP-MS and Quality Evaluation

何淑欣 1吴娜 1杨承勇 1薛巧如1
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作者信息

  • 1. 广东省药品检验所,广东 广州 510180
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摘要

目的:建立脂肪乳注射液中铝含量的测定方法,探讨其合理的限度范围.方法:采用电感耦合等离子体-质谱法(ICP-MS法)对15家企业生产的69批脂肪乳注射液的铝含量进行测定,针对脂肪乳注射液在ICP-MS法测定中内标元素的选择、定量方法、介质、样品前处理方法以及方法学的建立进行研究.结果:所测得的铝浓度在0.5 ng∙mL-1~5.0 ng∙mL-1 内线性关系良好,相关系数(r)为0.9999,平均回收率为 101.1%,RSD为 1.83%(n=9).结论:ICP-MS法适用于脂肪乳注射液中铝含量的测定.国内该类制剂的铝含量不同生产企业间存在较大差异,有必要控制大容量肠外营养制剂中脂肪乳注射液铝的残留量.

Abstract

Objective:To establish a method for the determination of aluminum content in fat emulsion injection and explore its reasonable limit range.Methods:The aluminum content of 69 batches of fat emulsion injection produced by 15 enterprises was determined using ICP-MS.The selection of internal standard elements,quantitative methods,media,sample pretreatment methods,and methodological establishment of fat emulsion injection in ICP-MS were studied.Results:There was a good linear relationship of ICP-MS in the concentration range of 0.5 ng∙mL-1~5.0 ng∙mL-1(r=0.9999),and the average recovery was 101.1%,RSD=1.83%(n=9).Conclusion:ICP-MS method is suitable for the determination of aluminum ion content in fat emulsion injection.There is a significant difference in residues of aluminum between the products from different manufacturers and it is necessary to control residual aluminum in fat emulsion injection.

关键词

ICP-MS法//脂肪乳注射液/含量/质量评价

Key words

ICP-MS/aluminum/fat emulsion injection/content/quality evaluation

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基金项目

广东省医学科学技术研究基金项目(B2023322)

广东省医学科学技术研究基金项目(B2023270)

出版年

2024
广东化工
广东省石油化工研究院

广东化工

影响因子:0.288
ISSN:1007-1865
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