Journal of Pharmaceutical and Biomedical Analysis Open最新文献_第5页

Laser-induced graphene electrodes obtained by direct laser writing for pharmaceutical and biomedical analysis 激光诱导石墨烯电极，直接激光写入，用于制药和生物医学分析

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-03-01 DOI: 10.1016/j.jpbao.2025.100069

Amal Rabti , Sabrine Baachaoui , Mohamed Zouari , Noureddine Raouafi

Laser-induced graphene (LIG), also referred to as laser-ablated graphene (LAG), laser-scribed graphene (LSG), laser-produced graphene (LPG), laser-engineered graphene (LEG), and laser-derived graphene (LDG), has emerged as a versatile material for the development of high-performance electrodes that exhibit unique properties, such as high electrical conductivity, large surface area, chemical stability, and ease of functionalization. These characteristics render LIG electrodes particularly suitable for pharmaceutical and biomedical applications where rapid, sensitive, and reliable analytical methods are required. This review presents a comprehensive overview of recent advancements in the utilization of graphene electrodes for pharmaceutical and biomedical applications. They encompass their fabrication processes, surface modifications with nanomaterials and biomolecules, and the principal analytical techniques employed, including electrochemical sensing, biosensing, and drug monitoring. Particular emphasis is placed on the integration of LIG electrodes into point-of-care devices for clinical diagnostics and therapeutic drug monitoring, as well as their role in detecting biomarkers and pharmaceutical residues. Furthermore, the challenges and future perspectives for LIG electrodes in achieving widespread adoption in the biomedical and pharmaceutical fields are examined, underscoring the need for improved scalability, selectivity, and regulatory compliance. This review elucidates the transformative potential of LIG-based technologies for addressing emerging healthcare challenges through innovative and cost-effective analytical solutions.

激光诱导石墨烯（LIG），也被称为激光烧烧石墨烯（LAG）、激光刻写石墨烯（LSG）、激光生产石墨烯（LPG）、激光工程石墨烯（LEG）和激光衍生石墨烯（LDG），已经成为一种多功能材料，用于开发高性能电极，具有高导电性、大表面积、化学稳定性和易于功能化等独特性能。这些特性使得LIG电极特别适用于需要快速、敏感和可靠分析方法的制药和生物医学应用。本文综述了石墨烯电极在制药和生物医学应用方面的最新进展。它们包括它们的制造过程，纳米材料和生物分子的表面修饰，以及所采用的主要分析技术，包括电化学传感，生物传感和药物监测。特别强调的是将LIG电极整合到临床诊断和治疗药物监测的护理点设备中，以及它们在检测生物标志物和药物残留方面的作用。此外，研究了LIG电极在生物医学和制药领域广泛应用所面临的挑战和未来前景，强调了提高可扩展性、选择性和法规遵从性的必要性。这篇综述阐明了基于lige的技术通过创新和具有成本效益的分析解决方案解决新兴医疗保健挑战的变革潜力。

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引用次数: 0

A novel microextraction method for further elemental impurity determination in oily pharmaceutical excipients by ICP-MS ICP-MS微萃取法进一步测定含油药用辅料中元素杂质

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-03-01 DOI: 10.1016/j.jpbao.2025.100063

Cristian Rafael Andriolli , Mariele Samuel Nascimento , Alessandra Schneider Henn , Eder Lisandro Moraes Flores , Erico Marlon Moraes Flores , Rochele Sogari Picoloto

In this study, a reversed-phase dispersive liquid-liquid microextraction (RP-DLLME) method was proposed for the subsequent determination of elemental impurities of class 1 (As, Cd, Hg, and Pb) and class 2 A (Co, Ni, and V) in oily pharmaceutical excipients, as recommended by the International Council for Harmonisation (ICH) guideline Q3D. Analyte determination was carried out by inductively coupled plasma mass spectrometry (ICP-MS). Operational parameters were evaluated, including dispersant and extractant solvents, total volume and proportion of the extraction solution, sample mass, temperature, heating time, centrifugation, and stirring. Suitable results were obtained using a high sample mass (5 g), 2 mL of 50:50 % (v/v) of n-propanol:HNO₃ (3 mol L⁻¹ HNO₃ for all analytes and 6 mol L⁻¹ HCl only for Hg), heating at 85 °C for 20 min, stirring for 1 min, and centrifugation for 10 min. Accuracy was assessed using certified reference materials (CRMs) of mineral oil, comparison with a reference method (microwave-assisted wet digestion), and analyte recovery experiments at three concentration levels, following ICH Q3D recommendations and the United States Pharmacopeia (USP) guidelines for injectable drugs. No statistical differences were observed in any of the accuracy assessments. The method achieved low quantification limits (LOQs) of 0.045, 0.006, 0.006, 0.009, 0.040, 0.020, and 0.102 µg g⁻¹ for As, Cd, Co, Hg, Ni, Pb, and V, respectively, all of which were below the maximum levels allowed by the ICH guideline. The proposed method presented several advantages for routine analysis, including simplicity, high throughput, the use of diluted solutions, and minimal laboratory waste generation.

在本研究中，根据国际协调理事会（ICH）指南Q3D的推荐，提出了一种反相分散液液微萃取（RP-DLLME）方法，用于后续测定含油药物辅料中1类（As, Cd, Hg, Pb）和2类 a （Co, Ni， V）元素杂质。分析物采用电感耦合等离子体质谱法（ICP-MS）测定。评估操作参数，包括分散剂和萃取剂溶剂，萃取溶液的总体积和比例，样品质量，温度，加热时间，离心和搅拌。合适的结果使用高样品质量(5 g), 2 毫升的50:50 % (v / v)的正丙醇:硝酸(3 摩尔硝酸 L−1对所有分析物和6 摩尔 L−1只HCl Hg),加热在85°C 20分钟,搅拌1 分钟,离心 10分钟。根据ICH Q3D建议和美国药典（USP）注射药物指南，使用矿物油认证标准物质（crm）、与标准方法（微波辅助湿消化）的比较以及三种浓度水平下的分析物回收率实验来评估准确性。在任何准确性评估中均未观察到统计学差异。该方法对As、Cd、Co、Hg、Ni、Pb和V的定量限（loq）分别为0.045、0.006、0.006、0.009、0.040、0.020和0.102 µg g−1，均低于ICH指南允许的最大限量。所提出的方法具有常规分析的几个优点，包括简单、高通量、使用稀释溶液和最小的实验室废物产生。

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引用次数: 0

Turning diverse analytical data into actionable knowledge for enzymatically driven polysorbate degradation risk assessment and control in biotherapeutic protein formulations 将不同的分析数据转化为生物治疗蛋白制剂中酶驱动的聚山梨酸酯降解风险评估和控制的可操作知识

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-02-24 DOI: 10.1016/j.jpbao.2025.100068

Alex Dow , Divya Chandra , Ximeng Dow , Benjamin Adams , Morgan Ayres , Shannon Rivera , Rong-Sheng Yang , Anita P. Liu , Xuanwen Li , Tingting Jiang , Fengqiang Wang , Tony Pereira , Rosalind Ang , Chunyan Li , Lei Zhang , Jonathan Welch , Lloyd Breunig

In recent years polysorbate (PS) degradation in biotherapeutic protein formulations has become one of the most challenging topics for residual host cell protein control. With such focus, various assays have been showcased to help inform on enzymatically driven PS degradation risk assessment and control. Access to multiple, orthogonal data sets can improve understanding but also increases complexity in data interpretation. To highlight how multiple assays can work together to provide an aligned enzymatically driven PS degradation risk assessment and control, three cases studies are discussed. The case studies are diverse in the driver for performing these experiments along with if they are proactively or reactively addressing PS degradation. From these three case studies it becomes apparent that assays are consistent in their use and alignment regarding enzymatically driven PS degradation risk assessment and control. In general, an assay will fall into one of three categories: risk informing, characterization, and extended characterization. With this information future work focused on enzymatically driven PS degradation risk assessment and control has a blueprint for what assays can be used and what the data informs on.

近年来，生物治疗蛋白制剂中聚山梨酸酯（PS）的降解已成为残留宿主细胞蛋白控制中最具挑战性的课题之一。有了这样的重点，各种分析已经展示，以帮助告知酶驱动的PS降解风险评估和控制。访问多个正交数据集可以提高理解能力，但也增加了数据解释的复杂性。为了强调多种检测方法如何协同工作，以提供一致的酶驱动的PS降解风险评估和控制，本文讨论了三个案例研究。在执行这些实验的驱动因素以及它们是主动还是被动地解决PS退化问题方面，案例研究是多种多样的。从这三个案例研究中，很明显，在酶驱动的PS降解风险评估和控制方面，测定法的使用和校准是一致的。一般来说，一个分析将落入三类之一：风险通知，表征和扩展表征。有了这些信息，未来的工作重点将放在酶驱动的PS降解风险评估和控制上，这就为可以使用什么检测方法和数据提供了一个蓝图。

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引用次数: 0

Innovative QSRR modeling approach for the development of an ultra-sensitive LC-MS/MS method for trace analysis of N-nitrosamines 创新的QSRR建模方法用于开发n -亚硝胺痕量分析的超灵敏LC-MS/MS方法

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-02-19 DOI: 10.1016/j.jpbao.2025.100064

Yue Zhang, Sabah Houari, Thomas Van Laethem, Amandine Dispas, Eric Ziemons, Philippe Hubert, Cédric Hubert

To address regulatory concerns regarding N-nitrosamine contamination in pharmaceutical products, generic LC-MS/MS methods for determining N-nitrosamines were developed using an innovative in silico approach based on Quantitative Structure Retention Relationship modeling (QSRR). The development process included screening and optimization phases, offering flexibility in targeting N-nitrosamines and addressing the challenges related to the matrix effect. This methodology represents a significant advancement in method development. Among the developed methods, a highly sensitive and accurate LC-MS/MS method was successfully validated to simultaneously determine 5 small-molecule N-nitrosamine impurities in tablets, which was used in the present proof-of-concept study. The validation followed the ICH Q2 (R2) guidelines, employing a combined approach for accuracy and precision based on total error risk-based methodology. The method was validated to function as both an impurity limit test and a quantitative method. Validation results demonstrated adequate quantitative performance of the method, establishing a validated dosing range from 1 to 30 ng/mL for all N-nitrosamines. The estimated detection limit ranged from 0.75 pg/mL to 0.02 ng/mL. The detection and quantification limits for each N-nitrosamine met the EMA N-nitrosamine investigation approach requirements. Moreover, both are always below 10 % of their respective acceptable limit in the studied finished product formulation. This proposed method is suitable for investigating small-molecule N-nitrosamines in pharmaceutical products and also provides a starting point for further method development, particularly for the determination of newly identified small-molecule N-nitrosamines and drug-substance-related N-nitrosamines.

为了解决药品中n -亚硝胺污染的监管问题，使用基于定量结构保留关系模型（QSRR）的创新硅方法开发了通用的LC-MS/MS检测n -亚硝胺的方法。开发过程包括筛选和优化阶段，提供了针对n -亚硝胺的灵活性，并解决了与基质效应相关的挑战。这种方法代表了方法开发的重大进步。其中，高效液相色谱-质谱联用（LC-MS/MS）方法可同时测定片剂中5种小分子n -亚硝胺类杂质，并用于概念验证研究。验证遵循ICH Q2 （R2）指南，采用基于总误差风险方法的准确度和精密度相结合的方法。结果表明，该方法既可作为杂质限检方法，又可作为定量方法。验证结果表明该方法具有足够的定量性能，建立了所有n -亚硝胺的有效剂量范围为1至30 ng/mL。估计检出限范围为0.75 pg/mL至0.02 ng/mL。各n -亚硝胺的检出定量限均符合EMA n -亚硝胺调查方法要求。此外，在研究的成品配方中，两者始终低于各自可接受限度的10% %。该方法适用于研究药品中的小分子n -亚硝胺，也为进一步的方法开发提供了起点，特别是对于新鉴定的小分子n -亚硝胺和与药物相关的n -亚硝胺的测定。

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引用次数: 0

IrO2 nanoparticles-doped bacterial cellulose as a paper-based platform for optical detection of dopamine IrO2纳米颗粒掺杂细菌纤维素作为多巴胺光学检测的纸质平台

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-02-19 DOI: 10.1016/j.jpbao.2025.100065

Handenur Tomaşoğlu , Eda Gumus , Erhan Zor , Haluk Bingol

Paper-based sensors including different indicators are attractive to many scientists because they can be used in many different fields. Due to their visual interpretability and ease of use, a large number of paper-based sensors have been created as competitors to traditional detection methods. In particular, the application of nanomaterials with different strategies to paper-based biosensors can provide an enhanced colorimetric readout for selective and sensitive detection. Among them, the numerous hydroxyl groups on IrO₂ nanoparticles (IrO₂NPs) surface made it easier for organic molecules to be adsorbed, leading to optical change of IrO₂NPs in the presence of biologically important molecules as analyte. In this study, a paper-based optical sensor platform was obtained using bacterial cellulose (BC) doped with IrO₂NPs. The IrO₂NPs-doped BC (IrO₂NPs@BC) was cut into circular pieces (spot) for easily handling and used for dopamine detection. The dopamine sensor showed linear response in a concentration range of 0.30 µM to 10 µM in solution, while it revealed a linear range of 0.60 mM to 2.5 mM in paper-based platform. Limit of detection (LOD) and limit of quantification (LOQ) values were determined to be 0.107 µM and 0.325 µM in solution media, and to be 0.479 mM and 1.45 mM for the proposed paper-based optical sensor platform, respectively.

包括不同指标的纸质传感器因其可用于许多不同领域而受到许多科学家的青睐。由于其视觉可解释性和易用性，大量基于纸张的传感器已经被创造出来，作为传统检测方法的竞争对手。特别是，将不同策略的纳米材料应用于基于纸张的生物传感器可以为选择性和灵敏度检测提供增强的比色读数。其中，IrO2纳米颗粒（IrO2NPs）表面大量的羟基使得有机分子更容易被吸附，导致IrO2NPs在有重要生物学分子作为分析物存在时发生光学变化。在本研究中，利用细菌纤维素（BC）掺杂IrO2NPs获得了基于纸张的光学传感器平台。将iro2nps掺杂的BC （IrO2NPs@BC）切成圆形块（点），便于处理，用于多巴胺检测。多巴胺传感器在溶液浓度为0.30 µM至10 µM范围内呈线性响应，在纸质平台上呈0.60 µM至2.5 µM线性响应。溶液介质的检出限（LOD）和定量限（LOQ）分别为0.107 µM和0.325 µM，纸质光学传感器平台的检出限（LOD）和定量限（LOQ）分别为0.479 mM和1.45 mM。

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引用次数: 0

Nanohybrids based on multi-walled carbon nanotubes and MOF-199: Advantages on the electrochemical reduction of hydrogen peroxide and sensing applications 基于多壁碳纳米管和MOF-199的纳米杂化材料：过氧化氢电化学还原及传感应用的优势

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-02-18 DOI: 10.1016/j.jpbao.2025.100066

Pablo A. Gallay , Virginia M. Vaschetti , Facundo Aghemo , Pablo R. Dalmasso , Gustavo A. Rivas

We report the advantages of a nanohybrid obtained through the integration of multi-walled carbon nanotubes (MWCNTs) and MOF-199 by sono-synthesis. The resulting nanohybrid presents important synergic effects on the catalytic reduction of hydrogen peroxide due to the facilitated regeneration of the catalytic center in the presence of the interconnected carbon nanomaterial. Glassy carbon electrodes (GCE) modified with this hybrid nanomaterial dispersed in Nafion allowed the sensitive quantification of hydrogen peroxide: linear range between 5.0 × 10⁻⁶ M and 7.5 × 10⁻⁵ M (R² = 0.997), with a sensitivity of (128 ± 3) x 10² µA M⁻¹, a detection limit of 2 µM, and a reproducibility of 8.0 % for the same nanohybrid and 5 different electrodes allowing the competitive electrochemical determination of hydrogen peroxide. The sensor was successfully used for the quantification of this important analyte in diverse commercial samples (milk, human serum, contact lens disinfecting solution, and mouthwash).

我们报道了多壁碳纳米管（MWCNTs）和MOF-199通过声合成得到的纳米杂化材料的优点。所得到的纳米杂化物对过氧化氢的催化还原表现出重要的协同效应，这是因为在相互连接的碳纳米材料的存在下，催化中心的再生更加容易。玻碳电极(GCE)修改该混合纳米材料分散在全氟磺酸允许过氧化氢的敏感量化:线性范围介于5.0 × 10−6 M和7.5 × 10−5 M (R2 = 0.997)的灵敏度(128 ± 3)x 102µ M−1、2的检测极限 µM和8.0 %的再现性相同的nanohybrid和5种不同电极允许竞争电化学测定过氧化氢。该传感器已成功用于多种商业样品（牛奶、人血清、隐形眼镜消毒液和漱口水）中这一重要分析物的定量。

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引用次数: 0

Progress and future directions in determining drugs using spectroelectrochemical methods 光谱电化学测定药物的研究进展及未来发展方向

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-02-18 DOI: 10.1016/j.jpbao.2025.100067

Vildan Sanko , Ozge Surucu , Filiz Kuralay

The use of drugs is essential for the continuity of human health and the prevention of diseases for living creatures. A key factor in effective drug use is taking it at the correct dosage and timing. Otherwise, some adverse or side effects of these drugs may occur. For this reason, it is crucial to determine the drugs used. In some cases, drug analysis is also essential to understand the use of harmful active substances, such as in the class of prohibited ones. The simple definition of a drug (medication) is a chemical substance that produces a biological effect when adapted to an organism. There are many techniques to determine the drug amount, including spectrometric, chromatographic, electrochemical, colorimetric, or immunological. These analytical techniques have been successfully used to quantify drugs. To improve the effectiveness of the detection protocols, combined systems such as spectroelectrochemistry (SEC) provide significant advantages. This well-known technique unites the principles of spectroscopy and electrochemistry by creating a synergy to provide information on redox properties, mechanisms, and molecular structures. This review highlights the transformative potential of SEC in determining drug molecules, offering a detailed exploration of its principles, methodologies, and unique advantages. The main emphasis, however, is on the use of SEC in pharmaceutical analysis, where its accuracy and adaptability have driven significant progress. Recent studies are presented in detail, demonstrating SEC's effectiveness in detecting, quantifying, and characterizing drug molecules with high sensitivity and specificity.

药物的使用对于维持人类健康和预防生物疾病是必不可少的。有效用药的一个关键因素是在正确的剂量和时间服用药物。否则，这些药物可能会产生一些不良或副作用。因此，确定使用的药物是至关重要的。在某些情况下，药物分析对于了解有害活性物质的使用也是必不可少的，例如在违禁物质的类别中。药物（药物）的简单定义是一种化学物质，当适应于生物体时产生生物效应。测定药物量的方法有很多，包括光谱法、色谱法、电化学法、比色法或免疫学法。这些分析技术已成功地用于定量药物。为了提高检测方案的有效性，光谱电化学（SEC）等组合系统提供了显着的优势。这种众所周知的技术通过创造一种协同作用，将光谱学和电化学原理结合起来，提供有关氧化还原性质、机制和分子结构的信息。这篇综述强调了SEC在确定药物分子方面的变革潜力，提供了其原理、方法和独特优势的详细探索。然而，主要的重点是在药物分析中使用SEC，其准确性和适应性已经推动了重大进展。最近的研究详细介绍了SEC在检测、定量和表征药物分子方面的有效性，具有高灵敏度和特异性。

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引用次数: 0

Developments toward analysis of pesticides at residue levels among High Chlorophyll Containing Edible Leafy Plants – Sampling, QuEChERS and LC-MS/MS based analysis 高叶绿素食用叶类植物农药残留分析研究进展——取样、QuEChERS和LC-MS/MS分析

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-02-12 DOI: 10.1016/j.jpbao.2025.100062

Vikrant Goel , Deepika Pandey , Sudeep Shukla

The usage of pesticides is crucial in maintaining the long-term health of plantations and boosting crop productivity. Nonetheless, their uncontrolled application has led to contamination of the environment, primarily affecting crops, soil, and water resources. Leafy plants rich in chlorophyll, classified as superfoods, have enhanced the quality of human life, however, they are prone to contamination with foreign contamination compounds known as xenobiotics, which pose a challenge for routine laboratory analysis. This paper reviews advancements among various sample preparation techniques evolving towards modern QuEChERS methodology and the features of the liquid chromatography mass spectroscopy technique that are useful for the assessment of pesticides from multiple classes at residue levels in such highly nutritious substances from High Chlorophyll Containing Edible Leafy Plants.

农药的使用对于维持种植园的长期健康和提高作物生产力至关重要。然而，它们不受控制的使用导致了环境污染，主要影响到作物、土壤和水资源。富含叶绿素的叶状植物被列为超级食物，提高了人类的生活质量，然而，它们容易受到外来污染化合物的污染，这对常规实验室分析构成了挑战。本文综述了向现代QuEChERS方法发展的各种样品制备技术的进展，以及液相色谱-质谱技术的特点，这些技术可用于评估高叶绿素食用叶植物中高营养物质中多类农药的残留水平。

引用次数: 0

Highly selective and sensitive detection of atorvastatin from using a MIP-based electrochemical sensor 基于mip的电化学传感器对阿托伐他汀的高选择性和高灵敏度检测

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-02-03 DOI: 10.1016/j.jpbao.2025.100061

Ensar Piskin , Fatih Ahmet Korkut , Ahmet Cetinkaya , Sibel A. Ozkan

Atorvastatin (ATR) is one of the statins that are widely used all around the world. This study presents a molecularly imprinted polymer (MIP) based electrochemical sensor for the sensitive and selective detection of ATR in binary mixtures and commercial serum samples. The designed sensor was fabricated using a photopolymerization (PP) approach on a glassy carbon electrode (GCE) using ATR as the template and acrylamide (ACR) as the functional monomer. The developed ATR/ACR@MIP-GCE sensor was evaluated electrochemically and morphologically using electrochemical impedance spectroscopy (EIS), cyclic voltammetry (CV), and scanning electron microscopy (SEM). The indirect measuring method was used with a 5.0 mM [Fe(CN)₆]^3–/4– solution to determine the ATR in the linear range of 1.0–10.0 pM. Moreover, the sensor demonstrated excellent linearity and extremely sensitive quantification (LOQ) limit of detection (LOD) values in both biological media and standard solutions. It also performed well in terms of specificity by effectively differentiating ATR from compounds with similar structures. Excellent repeatability and reproducibility results have confirmed the reliability of the sensor. The selectivity of the ATR/ACR@MIP-GCE sensor for ATR was proven by interference studies on ezetimibe and their binary mixtures.

阿托伐他汀（ATR）是世界上广泛使用的他汀类药物之一。本研究提出了一种基于分子印迹聚合物（MIP）的电化学传感器，用于灵敏和选择性地检测二元混合物和商业血清样品中的ATR。设计的传感器以ATR为模板，丙烯酰胺（ACR）为功能单体，采用光聚合（PP）方法在玻璃碳电极（GCE）上制备。利用电化学阻抗谱（EIS）、循环伏安法（CV）和扫描电镜（SEM）对研制的ATR/ACR@MIP-GCE传感器进行了电化学和形态学评价。间接测量法采用5.0 mM [Fe(CN)6]3 - /4 -溶液，在1.0 ~ 10.0 pM线性范围内测定ATR。此外，该传感器在生物培养基和标准溶液中均表现出良好的线性和极灵敏的定量（LOQ）检测限（LOD）值。它还表现出良好的特异性，可以有效地将ATR与具有相似结构的化合物区分开来。优异的重复性和再现性结果证实了该传感器的可靠性。通过对依折替米贝及其二元混合物的干扰研究，证明了ATR/ACR@MIP-GCE传感器对ATR的选择性。

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引用次数: 0

Assessment of the serum and salivary free light chain levels in patients with proteinuria post cardiac surgery 心脏手术后蛋白尿患者血清和唾液游离轻链水平的评估

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-02-01 DOI: 10.1016/j.jpbao.2025.100058

Moazaz Rashad Saed , Thikra Hasan Mathkor

Acute kidney injury (AKI) is a prevalent complication following cardiac surgery, affecting both short- and long-term survival rates. Proteinuria serves as an indicator of structural kidney damage and is increasingly recognized as a crucial marker for kidney disease and a risk factor for AKI. Free light chains (FLCs) are being investigated as potential markers for assessing the risk of kidney damage. This study aimed to validate the early detection of AKI by examining FLCs (kappa, lambda, and the kappa/lambda ratio) in serum and saliva samples. Clinical data were collected from 149 patients who underwent cardiac surgery in Baghdad, with 90 providing both saliva and serum samples for FLC evaluation. Patients were categorized based on the severity of proteinuria. Results showed that serum kappa levels were significantly elevated in patients with severe proteinuria compared to those with mild or no proteinuria. Conversely, salivary kappa levels were higher in patients with mild proteinuria than in those with severe or no proteinuria, while salivary lambda levels decreased as proteinuria severity increased. The rise in serum kappa may be attributed to immune system activation and kidney impairment. Both serum and salivary kappa demonstrated strong predictive capabilities for post-surgery AKI prognosis, outperforming lambda and the kappa/lambda ratio based on ROC analysis. The findings suggest that FLCs, particularly kappa, could be valuable in the early detection of AKI following cardiac surgery, highlighting their potential to enhance patient outcomes through proactive monitoring and intervention.

急性肾损伤（AKI）是心脏手术后常见的并发症，影响短期和长期生存率。蛋白尿作为结构性肾脏损害的指标，越来越被认为是肾脏疾病的重要标志和AKI的危险因素。游离轻链（FLCs）作为评估肾损害风险的潜在标记物正在被研究。本研究旨在通过检测血清和唾液样本中的FLCs （kappa、lambda和kappa/lambda比值）来验证AKI的早期检测。临床数据来自巴格达接受心脏手术的149例患者，其中90例提供唾液和血清样本用于FLC评估。根据蛋白尿的严重程度对患者进行分类。结果显示，与轻度或无蛋白尿患者相比，重度蛋白尿患者血清kappa水平显著升高。相反，轻度蛋白尿患者的唾液kappa水平高于严重或无蛋白尿患者，而唾液lambda水平随着蛋白尿严重程度的增加而下降。血清kappa升高可能与免疫系统激活和肾脏损害有关。血清和唾液kappa对术后AKI预后的预测能力均较强，优于lambda和基于ROC分析的kappa/lambda比值。研究结果表明，flc，特别是kappa，在心脏手术后AKI的早期检测中可能是有价值的，突出了它们通过主动监测和干预提高患者预后的潜力。

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引用次数: 0