中国血液净化

中国血液净化 ›› 2026, Vol. 25 ›› Issue (03): 227-232.doi: 10.3969/j.issn.1671-4091.2026.03.011

• 基础研究 • 上一篇    下一篇

血液灌流器对硫酸吲哚酚吸附性能检测方法的比较

钟文倩   曲亚南   张秋婷   

  1. 510663 广州，1广东省医疗器械质量监督检验所
  • 收稿日期:2025-09-08 修回日期:2025-12-22 出版日期:2026-03-12 发布日期:2026-03-12
  • 通讯作者: 曲亚南 E-mail:306584736@qq.com
  • 基金资助:
    广东省医疗器械质量监督检验所检验技术创新项目(2024ZY06)

Comparative evaluation of the detection methods for indoxyl sulfate adsorption in hemoperfusion systems

ZHONG Wen-qian, QU Ya-nan, ZHANG Qiu-ting   

  1. Guangdong Medical Devices Quality Surveillance and Test Institute, Guangzhou 510663, China
  • Received:2025-09-08 Revised:2025-12-22 Online:2026-03-12 Published:2026-03-12
  • Contact: 510663 广州，1广东省医疗器械质量监督检验所 E-mail:306584736@qq.com

摘要： 目的 对比超高效液相色谱串联质谱法(liquid chromatography-tandem mass spectrometry，LC-MS/MS)与紫外分光光度法(ultraviolet–visible spectroscopy，UV-Vis)在血液灌流器硫酸吲哚酚(indoxyl sulfate，IS)吸附性能检测中的适用性，明确不同浓度下吸附效率的影响规律。 方法 LC-MS/MS法：采用乙腈沉淀蛋白处理含IS牛血浆，测定灌流前后IS浓度，建立0.085～1.308μg/ml线性模型(Y=36045.242X+763.841，R²=0.9987)；UV-Vis法：检测含IS牛血清白蛋白溶液，建立3.75～120.00 μg/ml双线性模型(Y=77.337X-0.5316,R²=0.9977；Y=93.014X-0.4991,R²=0.9996)；2种方法的精密度RSD＜5%；回收率LC-MS/MS：86%～110%、UV-Vis：91%～110%。 结果 LC-MS/MS：灵敏度高(LOQ=0.0212 μg/ml)、抗基质干扰强，适用于血浆样本的大批量检测；UV-Vis：适用于高浓度IS(＞3.75 μg/ml)的快速筛查，但受蛋白结合干扰显著。吸附规律：IS低浓度时(＜30 μg/ml)，分子扩散动力不足，效率较低；高浓度时(＞100μg/ml)时，吸附剂表面有效位点被占据，单位分子结合效率下降；IS浓度约为60μg/ml时，提供充足扩散动力，同时避免位点竞争，达到效率峰值。 结论 LC-MS/MS可成为血液灌流器IS吸附性能的核心检测方法，为质量标准建立提供依据；UV-Vis限用于吸附剂开发阶段的高浓度样本初筛。本研究为临床治疗优化与行业标准化提供关键技术支撑。

关键词: 血液灌流器, 硫酸吲哚酚, 吸附性能, 超高效液相色谱串联质谱, 紫外分光光度法, 尿毒症毒素

Abstract: Objective  Indoxyl sulfate (IS) is a typical uremic toxin accumulated in chronic kidney disease (CKD) patients, and higher IS level is closely associated with cardiovascular complications. Accurate evaluation of IS adsorption performance of hemoperfusion devices is essential for their clinical effectiveness. This study systematically compares the applicability of ultra-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) and ultraviolet-visible spectrophotometry (UV-Vis) in evaluating IS adsorption by hemoperfusion devices, and clarifies the impact of IS concentration on adsorption efficiency.  Method  LC-MS/MS: bovine plasma containing IS was treated with acetonitrile for protein precipitation. IS concentrations pre-/post-adsorption were quantified, establishing a linear model of 0.0850～1.3080μg/mL (Y=36045.242X + 763.841, R²=0.9987). UV-Vis: IS in bovine serum albumin solution was detected, demonstrating dual linear relationships of 3.75～120μg/mL (Y=77.337X - 0.5316, R²=0.9977; Y=93.014X - 0.4991, R²=0.9996). Both methods showed precision of RSD ＜5% and recovery rates of 86～110% (LC-MS/MS) and 91～110% (UV-Vis).  Result  LC-MS/MS has the advantages of high sensitivity (LOQ=0.0212μg/mL), strong anti-matrix interference, and suitability for batch plasma testing. UV-Vis is applicable for rapid screening of high-concentration IS (＞3.75μg/mL) but is significantly interfered by protein binding. For adsorption dynamics: at low IS concentrations (＜30μg/mL), insufficient molecular diffusion kinetics reduced efficiency; at high concentrations (＞100μg/mL), saturation of active sites decreased binding efficiency per molecule. Peak efficiency occurred at ～60μg/mL, balancing diffusion kinetics and site competition.  Conclusion LC-MS/MS serves as the core method for evaluating IS adsorption performance in hemoperfusion devices, providing a basis for quality standards. UV-Vis is limited to preliminary high-concentration screening during adsorbent development. This study offers critical technical support for optimizing clinical protocols and establishing industry standards.

Key words: Hemoperfusion device, Indoxyl sulfate, Adsorption performance, LC-MS/MS, UV-Vis spectrophotometry, Uremic toxin

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