Journal of Pharmaceutical and Biomedical Analysis Open最新文献_第3页

A green and robust LC–MS/MS bioanalytical method for sulopenem etzadroxil and probenecid: Optimization, validation, and pharmacokinetic application 绿色高效液相色谱-质谱/质谱联用分析苏罗培南依扎罗西和丙苯酸的方法：优化、验证及药动学应用

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-07-22 DOI: 10.1016/j.jpbao.2025.100083

Niloufer Tasnim Khazi, Kumaraswamy Gandla, Lalitha Repudi

A novel, green, and robust Liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was developed and validated for the simultaneous quantification of sulopenem etzadroxil and probenecid in rat plasma, with application to pharmacokinetic studies. Method development was guided by a Box–Behnken Design and response surface methodology, optimizing key chromatographic variables—ethanol proportion (40–60 %), flow rate (0.8–1.2 mL/min), and mobile phase pH (2.8–3.2)—to achieve maximum resolution, peak area, and analytical reproducibility. Chromatographic separation was performed on a Kromasil C18 column using ethanol and 0.1 % TFA (50:50, v/v) as the mobile phase. Mass spectrometric detection employed selected reaction monitoring in positive ion mode using an LC-MS/MS instrument. The method exhibited excellent linearity (10–400 ng/mL), low limits of detection (LOD: ∼3 ng/mL), and quantification (LOQ: ∼9 ng/mL) for both analytes, with recovery rates > 93 % and %CVs < 15 %. Greenness and sustainability assessments using analytical GREEnness metric (AGREE), analytical GREEnness metric for sample PREParation (AGREEprep), complementary green analytical procedure index (ComplexGAPI), Eco-Scale, and Blue applicability grade index (BAGI) confirmed the method’s environmental compatibility and analytical reliability, with scores exceeding 65 across all tools. This validated method demonstrates high sensitivity, reproducibility, and environmental responsibility, rendering it suitable for routine bioanalytical and pharmacokinetic applications.

建立了一种新型、绿色、可靠的液相色谱-串联质谱（LC-MS /MS）方法，用于同时定量大鼠血浆中舒洛培南依扎诺西和丙苯乙酯的含量，并将其应用于药代动力学研究。方法开发以Box-Behnken设计和响应面法为指导，优化关键色谱变量-乙醇比例（40-60 %）、流速（0.8-1.2 mL/min）和流动相pH(2.8-3.2)，以实现最大分辨率、峰面积和分析重复性。色谱分离采用Kromasil C18色谱柱，流动相为乙醇和0.1 % TFA （50:50, v/v）。质谱检测采用正离子模式选择反应监测，采用LC-MS/MS仪器。该方法对两种分析物均具有良好的线性（10-400 ng/mL）、低检出限（LOD: ~ 3 ng/mL）和定量（LOQ: ~ 9 ng/mL），回收率>； 93 %和% cv <； 15 %。使用分析性绿色度量（AGREE）、样品制备分析性绿色度量（AGREEprep）、互补绿色分析程序指数（ComplexGAPI）、生态尺度（Eco-Scale）和蓝色适用性等级指数（BAGI）的绿色和可持续性评估证实了该方法的环境兼容性和分析可靠性，所有工具的得分都超过65分。该验证方法具有高灵敏度、重复性和环境责任，适用于常规生物分析和药代动力学应用。

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引用次数: 0

N-nitrosamine risk assessment in pharmaceuticals: Where are we from a regulatory point of view in 2025? 药品中n -亚硝胺风险评估：从监管的角度来看，2025年我们在哪里？

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-07-21 DOI: 10.1016/j.jpbao.2025.100084

Yue Zhang, Joëlle Widart, Eric Ziemons, Philippe Hubert, Cédric Hubert

N-nitrosamines have been a concern for decades due to their potential mutagenicity and widespread occurrence across various matrices. While evidence suggests carcinogenicity in animals, their potential carcinogenicity in humans has prompted their initial inclusion in the “cohort of concern” since in ICH M7(R1), and the current ICH M7(R2) guideline is now in effect. Intensified control of N-nitrosamines began in 2018 following the detection of N-nitrosodimethylamine in valsartan-containing products. Subsequent investigations revealed N-nitrosamine contamination across multiple drug classes, triggering widespread recalls, withdrawals, and regulatory actions. Recently, the emergence of N-nitrosamine drug substance-related impurities and drug linker-related impurities has drawn additional regulatory attention. This review presents the methodologies used to determine the acceptable daily intake of N-nitrosamines and traces the evolution of regulatory guidelines, offering a comparative analysis of the 3-step investigation approaches adopted by the European Medicines Agency and Food and Drug Administration. It provides a comprehensive examination of potential root causes for N-nitrosamine contamination, outlines the analytical requirements for confirmatory testing, as well as mitigation strategies to prevent or minimize contamination. Additionally, the review summarizes risk assessment tools used to predict N-nitrosamine formation. By presenting a comprehensive workflow for impurity investigations, this review aims to assist industrial stakeholders in managing N-nitrosamine risks, ensuring regulatory compliance, and safeguarding public health.

n -亚硝胺由于其潜在的诱变性和广泛存在于各种基质中，几十年来一直受到关注。虽然有证据表明它们对动物具有致癌性，但它们对人类的潜在致癌性促使它们自ICH M7（R1）以来首次被列入“关注队列”，目前的ICH M7（R2）指南现已生效。在缬沙坦产品中检测到n-亚硝基二甲胺后，2018年开始加强对n-亚硝胺的控制。随后的调查显示，n -亚硝胺污染了多种药物类别，引发了大范围的召回、下架和监管行动。最近，n -亚硝胺类原料药相关杂质和药物连接物相关杂质的出现引起了监管部门的额外关注。本综述介绍了用于确定n -亚硝胺每日可接受摄入量的方法，并追溯了监管指南的演变，对欧洲药品管理局和食品药品管理局采用的三步调查方法进行了比较分析。它全面审查了n -亚硝胺污染的潜在根本原因，概述了验证性测试的分析要求，以及防止或尽量减少污染的缓解战略。此外，综述总结了用于预测n -亚硝胺形成的风险评估工具。通过介绍杂质调查的综合工作流程，本综述旨在帮助工业利益相关者管理n -亚硝胺风险，确保法规合规性，并维护公众健康。

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引用次数: 0

Comparative analysis of MS/MS search algorithms in label-free shotgun proteomics for monitoring host-cell proteins using trapped ion mobility and ddaPASEF 利用捕获离子迁移率和ddaPASEF监测宿主细胞蛋白的无标记鸟枪蛋白组学中MS/MS搜索算法的比较分析

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-07-21 DOI: 10.1016/j.jpbao.2025.100082

Somar Khalil, Michel Plisnier

Host cell proteins (HCPs) are critical quality attributes that can impact the safety, efficacy, and quality of biotherapeutics. Label-free shotgun proteomics is a vital approach for HCP monitoring, yet the choice of tandem mass spectrometry (MS/MS) search algorithms directly influences identification depth and quantification reliability. In this study, six prominent MS/MS search tools (Mascot, MaxQuant, SpectroMine, FragPipe, Byos, and PEAKS) were systematically benchmarked for their performance on complex samples spiked with isotopically labeled proteins from Chinese hamster ovary cells. The data were acquired using trapped ion mobility spectrometry and parallel accumulation–serial fragmentation in data-dependent acquisition mode. Key performance metrics, including peptide and protein identifications, data extraction precision, fold-change (FC) accuracy, linearity, and measurement trueness, were evaluated. A Bayesian modeling framework with Hamiltonian Monte Carlo sampling was employed to robustly estimate FC means and variances, alongside local false discovery rates through posterior probability calibration. Bayesian decision theory, implemented via expected utility maximization, was used to balance accuracy against posterior uncertainty and provide a probabilistic assessment of each tool’s performance. Through this cumulative analysis, variability across tools was observed: Byos and SpectroMine excelled in quantitative accuracy with minimal bias, FragPipe provided high precision and quantifiability, PEAKS offered deep protein coverage, Mascot showed strong trueness, and MaxQuant exhibited moderate identification performance with greater variability at lower spike levels. This study establishes a rigorous, data-driven framework for tool benchmarking and offers guidance for selecting MS/MS tools suited to HCP monitoring in biopharmaceutical development.

宿主细胞蛋白（HCPs）是影响生物治疗药物安全性、有效性和质量的关键质量属性。无标签霰弹枪蛋白质组学是监测HCP的重要方法，但串联质谱（MS/MS）搜索算法的选择直接影响鉴定深度和定量可靠性。在这项研究中，系统地对六个著名的MS/MS搜索工具（Mascot、MaxQuant、SpectroMine、FragPipe、Byos和PEAKS）在含有中国仓鼠卵巢细胞同位素标记蛋白的复杂样品上的性能进行了基准测试。数据采用捕获离子迁移率光谱法和数据依赖获取模式的平行累积-序列破碎法获取。关键性能指标，包括肽和蛋白质鉴定，数据提取精度，折叠变化（FC）准确性，线性度和测量准确性进行了评估。采用哈密顿蒙特卡罗抽样的贝叶斯建模框架稳健地估计FC均值和方差，并通过后验概率校准局部错误发现率。贝叶斯决策理论通过期望效用最大化实现，用于平衡准确性和后验不确定性，并提供每种工具性能的概率评估。通过这种累积分析，观察到不同工具之间的差异：Byos和SpectroMine在最小偏差的定量准确性方面表现出色，FragPipe提供高精度和可量化性，PEAKS提供深度蛋白质覆盖，Mascot具有很强的真实性，MaxQuant具有中等鉴定性能，在较低的峰值水平上具有较大的可变性。本研究建立了一个严格的、数据驱动的工具基准框架，并为选择适合生物制药开发中HCP监测的质谱/质谱工具提供指导。

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引用次数: 0

Design of experiments-assisted UPLC method for quantification of nitrosamine impurities in glimepiride and lobeglitazone sulfate: A green chemistry approach 格列美脲和硫酸洛贝列酮亚硝胺杂质定量的实验辅助超高效液相色谱法设计：绿色化学方法

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-05-05 DOI: 10.1016/j.jpbao.2025.100078

KiranKumar Chagarlamudi , Venkata Kanaka Srivani Maddala , Kumaraswamy Gandla

A robust ultra-performance liquid chromatography (UPLC) method was developed and systematically optimized using a Design of Experiments (DoE) approach for the simultaneous quantification of glimepiride, lobeglitazone sulfate, nitrosamine impurity-3 (IMP-3), and impurity-1 (IMP-1) in the marketed LOBG-G1 formulation. Critical method parameters, including organic phase composition, flow rate, and mobile phase pH, were identified through a comprehensive risk assessment and subsequently optimized using a Box-Behnken design. The final chromatographic conditions—50 % organic phase composition, a flow rate of 0.2 mL/min, and a mobile phase pH of 2.6—ensured efficient separation and quantification of all four analytes. The method was validated in accordance with ICH guidelines, demonstrating excellent linearity (r² > 0.999), high accuracy, and precision, with low relative standard deviation values. Stability studies conducted under different stress conditions revealed significant degradation of all four compounds in acidic, alkaline, and oxidative environments. Degradation products were further characterized using LC-MS/MS analysis, confirming their structural identity. In addition to its analytical performance, the method's environmental sustainability was evaluated using multiple green analytical chemistry assessment tools. The DoE-guided UPLC method offers a highly sensitive, selective, and reproducible analytical platform for the detection of nitrosamine impurities in antidiabetic drugs, providing enhanced method understanding while aligning with sustainability principles.

建立了一种高效液相色谱（UPLC）方法，并采用实验设计（DoE）方法进行了系统优化，用于同时定量上市的LOBG-G1制剂中格列美脲、硫酸洛贝列酮、亚硝胺杂质-3 （IMP-3）和杂质-1 （IMP-1）。通过综合风险评估确定了关键方法参数，包括有机相组成、流速和流动相pH，随后使用Box-Behnken设计进行了优化。最终色谱条件为有机相组成为50% %，流速为0.2 mL/min，流动相pH为2.6，确保了四种分析物的有效分离和定量。该方法按照ICH指南进行了验证，显示出良好的线性(r²>；0.999)，准确度高，精密度高，相对标准偏差值低。在不同的应激条件下进行的稳定性研究表明，这四种化合物在酸性、碱性和氧化环境下都有显著的降解。利用LC-MS/MS对降解产物进行进一步表征，确定了降解产物的结构特征。除了分析性能外，还使用多种绿色分析化学评估工具对该方法的环境可持续性进行了评估。doe指导的UPLC方法为检测抗糖尿病药物中的亚硝胺杂质提供了一个高灵敏度、选择性和可重复性的分析平台，增强了对方法的理解，同时符合可持续性原则。

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引用次数: 0

Advancing biomedical analysis: Harnessing laser-induced graphene for next-gen of low-cost sensor technology 推进生物医学分析：利用激光诱导石墨烯用于下一代低成本传感器技术

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-04-26 DOI: 10.1016/j.jpbao.2025.100077

Elsa Maria Materón , Liana Melo Lins de Azevedo , Juliana Martins Dias , Ketley Caroline Rocha Pereira , Gustavo Miguel Sousa , Matheus Santos Dias , Camila Marchetti Maroneze , Daiane Dias , Cecilia de Carvalho Castro Silva

As biosensors and biomedical devices gain increasing importance in everyday diagnostics and health status monitoring, the need to develop and improve their reliability and versatility becomes more pronounced. In this context, the search for new materials for biosensors and biomedical devices has intensified, leading to the emergence of laser-induced graphene (LIG) as a promising candidate. LIG's environmentally sustainable nature, cost-effectiveness, and significant potential for large-scale graphene production and directed writing electronics circuits make it very interesting. In this review, we provide an overview of the mechanisms and precursor materials involved in LIG production, strategies to enhance graphene properties through the in-situ generation of hybrid materials via direct laser writing, and the crucial role of LIG in the development of cost-effective, point-of-care, and wearable devices for medical diagnosis and real-time health status monitoring.

随着生物传感器和生物医学设备在日常诊断和健康状态监测中的重要性日益增加，开发和提高其可靠性和多功能性的需求变得更加明显。在这种背景下，对生物传感器和生物医学设备新材料的研究已经加强，导致激光诱导石墨烯（LIG）作为一个有前途的候选者出现。LIG的环境可持续性、成本效益以及大规模石墨烯生产和定向写入电子电路的巨大潜力使其非常有趣。在这篇综述中，我们概述了LIG生产的机制和前驱体材料，通过直接激光写入原位生成混合材料来增强石墨烯性能的策略，以及LIG在开发成本效益高、即时护理和可穿戴医疗诊断和实时健康状态监测设备中的关键作用。

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引用次数: 0

Determination of rapid and sensitive extraction of colchicine from Colchicum baytopiorum and Colchicum decaisnei leaves by HPLC-UV method 高效液相色谱-紫外分光光度法测定秋水仙叶和秋水仙叶中秋水仙碱的快速灵敏提取

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-04-22 DOI: 10.1016/j.jpbao.2025.100076

Efe Deniz , Ümit Babacan , Ceren Selim , Mehmet Fatih Cengiz

This study focuses on the extraction and analysis of colchicine, a bioactive alkaloid, from the leaves of two endemic species, Colchicum baytopiorum (n = 13) and Colchicum decaisnei (n = 11), collected from Antalya, Türkiye. Colchicine, known for its pharmacological applications for the treatment of gout and cancer, was extracted using ultrasonic-assisted extraction, a more environmentally friendly alternative to conventional methods like Soxhlet and solid-liquid extraction. High-performance liquid chromatography was used for the quantification of colchicine levels in the plant samples. The method was validated in terms of linear dynamic range, limit of detection (LOD), limit of quantification (LOQ) and relative standard deviation (RSD). Results showed that LOD, LOQ and RSD values were determined to be 0.210 ppm, 0.799 ppm and 1.420, respectively. C. baytopiorum had a higher colchicine content (206.24 ± 87.48 ppm) compared to C. decaisnei (11.23 ± 23.04 ppm). These findings are consistent with previous studies, which report varying colchicine concentrations across different Colchicum species. The study suggests that genetic research could help identify the specific genes responsible for colchicine production, which could enhance its availability in pharmaceutical applications. This research contributes to understanding colchicine extraction and its potential for medical use.

本研究对采自土耳其安塔利亚的两种特有植物秋水仙碱（Colchicum baytopiorum, n = 13）和秋水仙（Colchicum decaisnei, n = 11）的叶片进行了生物活性成分的提取和分析。秋水仙碱以其治疗痛风和癌症的药理应用而闻名，它是用超声波辅助提取的，这是一种比索氏提取和固液提取等传统方法更环保的选择。采用高效液相色谱法定量测定植物样品中秋水仙碱的含量。从线性动态范围、检出限（LOD）、定量限（LOQ）和相对标准偏差（RSD）等方面对该方法进行了验证。结果表明，测定的LOD、LOQ和RSD分别为0.210 ppm、0.799 ppm和1.420 ppm。秋水仙碱含量（206.24 ± 87.48 ppm）高于秋水仙碱含量（11.23 ± 23.04 ppm）。这些发现与先前的研究一致，这些研究报告了不同秋水仙属植物的秋水仙碱浓度不同。该研究表明，基因研究可以帮助确定负责秋水仙碱生产的特定基因，从而可以提高其在制药应用中的可用性。本研究有助于了解秋水仙碱的提取及其潜在的医学用途。

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引用次数: 0

Magnetic solid-phase extraction of Sudan dyes from beverages-coated magnetite/silica materials 饮料包覆磁铁矿/二氧化硅材料中苏丹红染料的磁固相萃取

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-03-12 DOI: 10.1016/j.jpbao.2025.100073

Yugao Guo , Xiaoxiao Niu , Boyu Li , Pei Liu , Youqing Sun , Sumin Lu

In this study, a polydopamine-coated magnetite/silica composite material (Fe₃O₄@SiO₂/PDA) was successfully synthesized and characterized using Fourier-transform infrared spectroscopy (FT-IR), X-ray diffraction (XRD), and X-ray photoelectron spectroscopy (XPS). By integrating EM-MSPE with high-performance liquid chromatography (HPLC), a novel EM-MSPE-HPLC method was established for the sensitive and accurate determination of Sudan I-IV dyes. Key experimental parameters, such as adsorbent dosage, pH, inorganic salt concentration, adsorption time, voltage, eluent type, eluent volume, and desorption time, were systematically investigated and optimized. Under optimal conditions, the method demonstrated excellent linearity (R² > 0.999) within a concentration range of 5–1000 μg L⁻¹, with limits of detection (LODs) ranging from 0.11 to 0.17 μg L⁻¹. The recoveries of Sudan dyes in real samples ranged from 89.1 % to 101.9 %, with relative standard deviations (RSDs) between 0.3 % and 3.6 %. Furthermore, the Fe₃O₄@SiO₂/PDA adsorbent exhibited consistent performance over ten consecutive extraction cycles without significant loss in recovery efficiency. These findings demonstrate that the proposed method is accurate, reliable, and reproducible for the simultaneous determination of Sudan dyes in complex beverage matrices, offering a robust analytical approach for food safety applications.

本研究成功合成了一种聚多巴胺包覆磁铁矿/二氧化硅复合材料（Fe3O4@SiO2/PDA），并利用傅里叶变换红外光谱（FT-IR）、x射线衍射（XRD）和x射线光电子能谱（XPS）对其进行了表征。将EM-MSPE与高效液相色谱（HPLC）相结合，建立了灵敏、准确测定苏丹红I-IV染料的EM-MSPE-HPLC新方法。对吸附剂用量、pH、无机盐浓度、吸附时间、电压、洗脱液类型、洗脱液体积、脱附时间等关键实验参数进行了系统的考察和优化。在最佳条件下，该方法具有良好的线性(R²>；0.999)，浓度范围为5-1000 μg L -⁻¹，检测限（lod）范围为0.11至0.17 μg L -⁻¹。苏丹红染料在实际样品中的回收率为89.1 % ~ 101.9 %，相对标准偏差（rsd）为0.3 % ~ 3.6 %。此外，Fe3O4@SiO2/PDA吸附剂在连续10次萃取循环中表现出一致的性能，且回收率没有明显下降。这些结果表明，该方法准确、可靠、可重复性好，可用于复杂饮料基质中苏丹红染料的同时测定，为食品安全应用提供了可靠的分析方法。

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引用次数: 0

Direct sample introduction in high-performance liquid chromatography analysis of oily medicinal cannabis samples using surfactant-free microemulsion 使用无表面活性剂微乳液对含油药用大麻样品进行高效液相色谱分析，直接进样

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-03-11 DOI: 10.1016/j.jpbao.2025.100075

Ana Paula Lamounier, Bárbara da Conceição Coelho Cotta Cardoso, Alessandra Licursi Maia Cerqueira da Cunha

The therapeutic use of medicinal Cannabis has raised challenges in quality control and cannabinoid quantification in oil extracts, primarily due to incompatibility with liquid chromatography systems. Surfactant-free microemulsion (SFME) systems offer a promising, efficient, and sustainable solution, enabling direct analysis by high-performance liquid chromatography. These microemulsions are dispersions of two immiscible liquids, typically oil and water, made compatible by an amphiphilic substance that interacts with both polar and nonpolar fractions. After SFME testing and critical analysis of the results, clear and homogeneous microemulsions were observed regardless of the oil-to-water ratio studied, provided that sufficient quantities of 1-octanol:1-propanol (3:10 v/v) were added. Based on the established robust working range, the 1:2 (oil:ultrapure water) ratio (% w/w) was chosen as the compromise condition, minimizing medicinal oil use while ensuring compatibility with the chromatographic system. Univariate optimization of chromatographic conditions enabled simultaneous analysis of five cannabinoids, including cannabidiol (CBD), cannabidiolic acid (CBDA), tetrahydrocannabutol (THCB), cannabinol (CBN), and tetrahydrocannabinol (Δ9-THC) using a ZORBAX Eclipse Plus C18 column at 35 °C. The method employed isocratic elution with a mobile phase of 82:18 %v/v methanol:ultrapure water containing 0.15 ± 0.05 % v/v formic acid, a 1.0 mL min⁻¹ flow rate, and a 20 μL injection volume, using the fluorescence and UV absorption detectors. This proposal offers sensitivity (LOD in the ng mL⁻¹), selectivity, and separation efficiency, associated with low cost, minimal waste generation, and low energy demand, aligning with Green Chemistry principles.

药用大麻的治疗用途在油提取物的质量控制和大麻素定量方面提出了挑战，主要是由于与液相色谱系统不相容。无表面活性剂微乳液（SFME）系统提供了一种有前途的、高效的、可持续的解决方案，可以通过高效液相色谱进行直接分析。这些微乳液是两种不相容的液体（通常是油和水）的分散体，通过与极性和非极性组分相互作用的两亲性物质使其相容。在SFME测试和结果的临界分析后，只要加入足够数量的1-辛醇：1-丙醇（3:10 v/v），无论所研究的油水比如何，都可以观察到清晰均匀的微乳液。基于已建立的稳健工作范围，选择1:2（油：超纯水）比（% w/w）作为折衷条件，在保证与色谱系统相容性的同时，最大限度地减少药用油的使用。采用ZORBAX Eclipse Plus C18色谱柱，对色谱条件进行单因素优化，可在35℃条件下同时分析五种大麻素，包括大麻二酚（CBD）、大麻二酸（CBDA）、四氢大麻酚（THCB）、大麻酚（CBN）和四氢大麻酚（Δ9-THC）。方法采用等容洗脱，流动相为82:18 %v/v甲醇：超纯水（含0.15 ± 0.05 % v/v甲酸），流速1.0 mL min−1，进样量20 μL，荧光和紫外吸收检测器。该方案提供了灵敏度（LOD在ng mL−1），选择性和分离效率，与低成本，最小的废物产生和低能源需求相关联，符合绿色化学原则。

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引用次数: 0

Interstitial fluid-based optical biosensors 基于间隙流体的光学生物传感器

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-03-10 DOI: 10.1016/j.jpbao.2025.100074

Atefeh Rahimzadeh , Abrisham Arjomandkhah , Mohammad Ali Kiani, Hamed Golmohammadi

The high reproducibility and reliability of optical biosensors, alongside the extraordinarily features of interstitial fluid (ISF) as a promising biological fluid with blood-like composition and yet noninvasive or minimally invasive sampling, have led to the development of a variety of the ISF-based optical biosensors for diagnostic and health monitoring applications. In the present review, while introducing ISF, its characteristics, and the methods developed for its sampling, various types of optical biosensors developed so far for the colorimetric, fluorometric, and surface-enhanced Raman spectroscopy determination of (bio)chemical compounds in ISF are reviewed. Lastly, future prospects and views on the main challenges facing the further development of ISF-based optical biosensors are delineated. Building upon the extraordinary features of ISF-based optical biosensors as highly promising and potential biosensors, we anticipate that they will be greatly welcomed and many of the existing blood-based optical biosensors will be replaced by ISF-based ones in the near future.

光学生物传感器的高重复性和可靠性，以及间质液（ISF）作为一种具有血液样成分的有前途的生物液体的非凡特征，以及非侵入性或微创性采样，导致了各种基于ISF的光学生物传感器的发展，用于诊断和健康监测应用。在本文中，介绍了生物纤维、生物纤维的特性和开发的采样方法，综述了迄今为止开发的用于比色法、荧光法和表面增强拉曼光谱法测定生物纤维中（生物）化合物的各种类型的光学生物传感器。最后，对基于isf的光学生物传感器进一步发展面临的主要挑战进行了展望和展望。鉴于基于isf的光学生物传感器作为一种非常有前途和潜力的生物传感器的非凡特性，我们预计它们将受到极大的欢迎，并且在不久的将来，许多现有的基于血液的光学生物传感器将被基于isf的光学生物传感器所取代。

引用次数: 0

How does HSA's antioxidant activity change under the influence of lincomycin and spectinomycin mixture? – A spectroscopic study 林可霉素与大观霉素混合作用对HSA的抗氧化活性有何影响？-光谱研究

Journal of Pharmaceutical and Biomedical Analysis Open

Pub Date : 2025-03-08 DOI: 10.1016/j.jpbao.2025.100070

Wojciech Rogóż, Aleksandra Owczarzy, Karolina Kulig, Małgorzata Maciążek-Jurczyk

Lincomycin (LIN) belongs to the lincosamides group and is used in bacterial infections of soft tissues, the respiratory system, bone marrow, and bones, while spectinomycin (SPE) belongs to the group of aminoglycoside antibiotics and is used for the treatment of gonorrhoea. Both antibiotics are commonly used to treat humans separately while their mixture is used in veterinary preparations (SPE-LIN), and the combination of these antibiotics has not yet been used for human treatment. The aim of this study was to search for modulators of human serum albumin (HSA) antioxidant activity among antibacterial drugs, lincomycin (LIN) and spectinomycin (SPE). In order to study the effect of LIN and SPE on HSA antioxidant properties the DPPH and ABTS tests were used. UV-Vis spectrophotometry and circular dichroism (CD) spectroscopic techniques were used to find the cause of LIN and SPE modulatory activity related to HSA antiradical potential. Both LIN and SPE, as well as their mixture, did not show significant antioxidant activity, while in combination with HSA, they stimulated its antioxidant properties. CD measurements determined that the dominant secondary structure of HSA, regardless of the presence of ligands, was α-helix, and its percentage share slightly increased under the influence of LIN and SPE. The obtained results confirm the viability of further studies on the potential application of the combination of SPE-LIN in the treatment, not only in breeding animals. The proposed concept of research may be a response to the future needs in medicine. The assumed goal, which was the search for HSA modulators, has been achieved.

林可霉素（Lincomycin， LIN）属于林可胺类药物，用于软组织、呼吸系统、骨髓和骨骼的细菌感染，而大观霉素（spectinomycin， SPE）属于氨基糖苷类抗生素，用于治疗淋病。这两种抗生素通常用于单独治疗人类，而它们的混合物用于兽医制剂（SPE-LIN），这些抗生素的组合尚未用于人类治疗。本研究的目的是在抗菌药物林可霉素（LIN）和大观霉素（SPE）中寻找人血清白蛋白（HSA）抗氧化活性的调节剂。为了研究LIN和SPE对HSA抗氧化性能的影响，采用DPPH和ABTS试验。利用紫外-可见分光光度法和圆二色（CD）光谱技术研究了LIN和SPE调节HSA抗自由基电位的原因。LIN和SPE及其混合物均不表现出显著的抗氧化活性，而与HSA结合后，则能激发其抗氧化性能。CD测定表明，无论配体是否存在，HSA的优势二级结构都是α-螺旋结构，在LIN和SPE的影响下，其百分比略有增加。所获得的结果证实了进一步研究SPE-LIN联合应用于治疗的可行性，而不仅仅是在育种动物中。提出的研究概念可能是对未来医学需求的回应。假设的目标，即寻找HSA调制器，已经实现。

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