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使用LC-MS/MS对血清因弗利西玛的无抗体量化

Xiaoshuang He¹, Juntao Zhao², Xiaoli Ma²

¹Department of Pharmacy, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai 200025, China.

Journal of pharmaceutical and biomedical analysis

|August 24, 2025

概括

一种无抗体的液体染色体-双重质谱法准确地测量了血清中的Infliximab (IFX) 水平. 这种技术为炎症性肠病 (IBD) 的治疗药物监测提供了更敏感和更强大的方法.

科学领域:

分析化学
药理学
免疫学

背景情况:

伊弗利西马布 (IFX) 是治疗炎症性肠病 (IBD) 的关键生物疗法.
血清IFX度与IBD临床结果相关.
与免疫试验相比,液体染色体-双重质谱 (LC-MS/MS) 的选择性和灵敏性更高.

研究的目的:

开发一种有效的,无抗体的LC-MS/MS方法来量化血清IFX水平.
验证该方法的准确性和精度.
将LC-MS/MS结果与免疫测试结果进行比较.

主要方法:

使用蛋白质G涂层磁珠从人体血清中捕获IFX和cadonilimab (内部标准).
通过LC-MS/MS进行了素消化和选择性分析.
将开发方法的结果与标准免疫试验进行比较.

主要成果:

获得良好的特异性,总精度在10.5%以内.
在0.5-100 mg/L线性范围内,已证明精度为92.8%至97.6%.
在样本分析中显示LC-MS/MS和免疫测试结果的一致性.

结论:

与现有的分析技术相比,开发的LC-MS/MS方法提供了更灵敏和更稳定的IFX测定.
这种方法对IBD治疗药物监测具有显著的潜力.
这种方法可以促进IBD患者的个性化治疗策略的开发.

关键词:

没有抗体炎症性肠道疾病其他药物一个LC-MS/MS

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