热力学平衡对加速稳定性的影响  

Effect of thermodynamic equilibrium on acceleration stability

作　　者：叶鹏茹 王万利 王萍 陶占领 渠海 YE Pengru;WANG Wanli;WANG Ping;TAO Zhanling;QU Hai(Zhengzhou Auto Bioengineering Co.,Ltd.,Zhengzhou,Henan 450016,China)

机构地区：[1]郑州安图生物工程股份有限公司,河南郑州450016

出　　处：《中国医学工程》2023年第6期23-27,共5页China Medical Engineering

摘　　要：目的体外诊断试剂的稳定性作为试剂体系的重要技术指标之一,在体外诊断试剂的质量和使用安全中具有重要的指导意义,本文主要以磁微粒β2-MG检测试剂盒为例,为解决磁微粒化学发光试剂稳定性提供一种新思路。方法通过对化学试剂进行热平衡处理,研究热平衡对稳定性的影响,以2~8℃校准品的发光值(RLU)为对照,测定经处理的试剂放置37℃10 d后的发光值的下降率(ROD)来观察稳定性的改善,并对其进行统计学分析。结果通过热平衡酶结合物的方式可显著提高磁微粒β2-MG试剂盒热加速稳定性。结论在不改变配方的条件下仅通过热平衡方式可以显著提高试剂热稳定性,为体外诊断试剂同行提供一种新思路。【Objective】The stability of in vitro diagnostic reagents,as one of the important technical indicators of reagent system,has important guiding significance in the quality and safety of in vitro diagnostic reagents.This paper mainly takes magnetic particleβ2-MG detection kit as an example to provide a new idea for solving the stability of magnetic particle chemiluminescence reagents.【Methods】The influence of thermal balance on stability was studied by thermal balance treatment of chemical reagents.Relative light unit(RLU)of calibrated products at 2℃to 8℃was used as a control.The rate of decline(ROD)of the luminescence value of the treated reagent after being placed at 37℃for 10 days was measured to observe the improvement of stability,and the statistical analysis was conducted.【Results】The thermal acceleration stability of magnetic particleβ2-MG kit could be significantly improved by thermal balance enzyme conjugation.【Conclusion】The thermal stability of the reagent can be significantly improved by thermal balance method without changing the formula,which provides a new idea for in vitro diagnostic reagent counterparts.

关 键 词：磁微粒化学发光试剂 热平衡 加速稳定性 

分 类 号：R197.39[医药卫生—卫生事业管理]