• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等

中国药物评价 ›› 2024, Vol. 41 ›› Issue (6): 470-476.

• 评价技术与方法 • 上一篇    下一篇

气相色谱法测定人血白蛋白中辛酸钠含量的不确定度分析

陈承贵, 王晓冲, 江坤*, 王平   

  1. 深圳市药品检验研究院,广东 深圳 518057
  • 收稿日期:2024-05-10 修回日期:2024-11-15 出版日期:2024-12-28 发布日期:2024-12-28

Uncertainty Analysis of determination of Sodium octanoate in Human Serum Albumin by Gas Chromatography

  1. Shenzhen Institute for Drug Control, Guangdong Shenzhen 518057, China
  • Received:2024-05-10 Revised:2024-11-15 Online:2024-12-28 Published:2024-12-28

摘要: 目的:气相色谱法测定人血白蛋白中辛酸钠含量,并对其进行不确定度评定。方法:采用酸改性聚乙二醇(30M)毛细管柱(DB-WAX),柱温160 ℃,火焰离子化检测器,检测器温度230 ℃,气化室温度230 ℃,流速为2 mL·min-1,进样量1 μL,以庚酸为内标,内标法定量;再建立计算含量的数学模型,找出影响不确定度的因素,并对各个分量进行评估。结果:本次血白蛋白中辛酸钠含量测定结果为0.159 mmol·g-1蛋白质,扩展不确定度为0.009 mmol·g-1蛋白质(k=2)。结论:本实验首次对人血白蛋白中辛酸钠含量不确定度分量进行分析和评定,其结果准确、可靠,为血液制品检验提供了误差分析;通过分析影响不确定度的因素,找出影响检测结果的主要原因,可提高检测结果的可信度。

关键词: font-size:medium, ">气相色谱法;人血白蛋白;辛酸钠;不确定度

Abstract: Objective: To establish an gas chromatography method for the content of sodium caprylate in human blood albumin and evaluate the uncertainty in the measurement. Methods: The acid modified polyethylene glycol (30M) capillary column (DB-WAX) was used, the column temperature was 160 ℃, the flame ionization detector was 230, the gasification chamber temperature was 230 ℃, the flow rate was 2 mL·min-1, the sample size was 1 μL, and the quantity was determined by internal standard method with enanthic acid as the internal standard. To build mathematical model to calculate the content, and find out the influence factors of uncertainty, and to evaluate each component. Results: The content of sodium capylate in human blood albumin was 0.159 mmol·g-1 protein, and the extended uncertainty was 0.009 mmol·g-1 protein (k=2). Conclusion: The uncertainty component of sodium caprylate content in human blood albumin was analyzed and evaluated for the first time. The results were accurate and reliable, which provided error analysis for blood product testing. By analyzing the factors affecting the uncertainty, the main reasons affecting the detection results are found out, and the reliability of the detection results is improved.

Key words: font-size:medium, ">Gas chromatography; Human serum albumin; Sodium octanoate; Uncertainty

中图分类号: