The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous abscess drainage for disinfection of deep tissue abscesses. The study includes three arms: (1) MB-PDT at a fixed drug/light dose plus standard of care abscess drainage , (2) MB-PDT at a patient-specific dose determined by pre-treatment optical measurements plus standard of care abscess drainage , and (3) standard of care abscess drainage. The primary endpoint is reduction in time to removal of the drainage catheter.

开始日期2026-07-15

申办/合作机构

University of Rochester

NCT07494773

/ Not yet recruiting临床1/2期IIT

Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection: A Prospective Randomized Pilot Study

Burn wound infections remain a major source of morbidity in patients with thermal injuries and contribute to delayed healing, graft loss, and prolonged hospitalization. The emergence of antimicrobial-resistant organisms further complicates management and highlights the need for non-antibiotic antimicrobial strategies. Photodynamic therapy (PDT) is an antimicrobial approach that combines a photosensitizing agent with visible light to generate reactive oxygen species capable of killing bacteria.
This randomized clinical trial will evaluate the safety and preliminary efficacy of methylene blue-mediated photodynamic therapy for the treatment of burn wound bacterial contamination. Participants receiving standard burn care will be randomized to receive either methylene blue-photodynamic therapy with blue light illumination or light therapy alone during routine dressing changes. Treatments will occur during two consecutive dressing changes. The primary objective is to determine whether methylene blue photodynamic therapy reduces bacterial burden in burn wounds compared with light therapy alone. Secondary outcomes include safety, tolerability, and effects on wound healing.

开始日期2026-06-01

申办/合作机构

University of Oklahoma

[+1]

NCT07179003

/ Not yet recruiting临床2期IIT

A Phase 2 Study of Methylene Blue Photodynamic Therapy for Treatment of Breast Abscesses

The objective of this Phase 2 study is to evaluate the efficacy of methylene blue photodynamic therapy (MB-PDT) performed at the time of percutaneous breast abscess drainage for disinfection of breast abscesses. The study includes two arms: (1) standard of care breast abscess drainage and (2) MB-PDT plus standard of care breast abscess drainage. The primary endpoint is time to resolution of clinical symptoms. Secondary endpoints include imaging evidence of abscess resolution, abscess recurrence, need for repeated intervention, and cure rate across treatment groups. Responses will be compared between the two study arms for the per protocol population to determine the efficacy of MB-PDT relative to standard of care. The investigators hypothesize that the addition of MB-PDT to standard of care will significantly reduce the time to symptom resolution, compared to standard of care alone.

开始日期2026-04-01

申办/合作机构

University of Rochester

100 项与亚甲蓝相关的临床结果

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100 项与亚甲蓝相关的转化医学

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100 项与亚甲蓝相关的专利（医药）

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55,373

项与亚甲蓝相关的文献（医药）

2026-05-01·VETERINARY ANAESTHESIA AND ANALGESIA

Ultrasound-guided interfascial rectus sheath–associated plane block in sheep: a cadaveric study

Article

作者: Re, Michela ; de Gaspar Simón, Ignacio ; Gómez de Segura, Ignacio A ; Bustamante, Rocío

OBJECTIVE:

To evaluate ovine anatomy to determine the feasibility of an ultrasound-guided interfascial rectus sheath (RS)-associated plane block in sheep cadavers.

STUDY DESIGN:

Prospective, experimental, randomized cadaveric study.

ANIMALS:

A group of 22 fresh cadavers (median 52 kg, range 47-62 kg).

METHODS:

In phase I, six cadavers underwent anatomical (n = 2) and ultrasonographic (n = 4) examination of the ventral abdominal wall and RS. Based on these findings, two lateral (one- or two-injection) approaches were defined. In phase II, 14 cadavers were randomly injected bilaterally using the one-injection approach under ultrasound guidance with 0.1% methylene blue at either high (HV, 0.5 mL kg^-1) or low (LV, 0.25 mL kg^-1) volume, targeting the plane between the rectus abdominis muscle (RAM) and its internal sheath. Dye distribution and nerve staining were evaluated by dissections.

RESULTS:

The one-injection approach provided better visualization and consistent nerve staining. The eleventh thoracic nerve was stained in all cases, whereas the twelfth (HV = 93%; LV = 79%) and thirteenth thoracic nerves were stained only in two cadavers with HV. Dye spread was limited, suggesting compartmentalization of the interfascial plane. Further investigation in two additional cadavers included injections of methylene blue and a neutral red dye (LV each) between RAM and its internal sheath between alternate muscle bellies. The latter injections were within the same unilateral RAM, separated by tendinous intersections. Dissection showed distinct dye accumulation without mixing.

CONCLUSIONS AND CLINICAL RELEVANCE:

The described approach produced a limited spread and nerve staining, possibly owing to ovine-specific anatomy and the technique used, which differs from the standard rectus sheath block (RSB) technique. Targeting individual muscular compartments could be an alternative. Further studies using the traditional RSB approach are needed to confirm its applicability in this species.

2026-05-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Zr-MOF boosted silver nanospheres for integrated SERS detection and solar photo-removal of hazardous contaminants

Article

作者: Li, Jumei ; Gui, Yiwen ; Chen, Ao ; Cai, Ning ; Li, Minzhe

In this study, Ag@NU-66 core-shell composites were synthesized by coating silver nanospheres with the metal organic framework (MOF)-UiO-66-NH₂ (Zr) using a straightforward hydrothermal technique. The resulting composite combines excellent stability, high enrichment capacity, and photocatalytic properties. As a SERS substrate, Ag@NU-66 effectively detected a range of harmful contaminants, with detection limits as low as 10^-9 M, 10^-8 M, and 10^-9 M for methylene blue, rhodamine 6G, and thiram, respectively. In addition, Ag@NU-66 exhibited efficient removal of these pollutants under simulated solar light photocatalysis. The dual functionality of the composite can be attributed to the enhanced electromagnetic field created by the plasmonic properties of silver nanospheres, along with improved charge transfer facilitated by the adsorption capabilities of UiO-66-NH₂. Furthermore, the Ag@NU-66 composites demonstrated superior stability compared to bare silver nanospheres in various solvents, even in oxidative conditions containing halide ions. These findings support the potential development of Ag@NU-66-based sensing and pollutant removal systems for environmental applications.

2026-04-01·JOURNAL OF PSYCHIATRIC RESEARCH

Metabolic shifts, a consequence of hyperosmolarity, are a hallmark of mental disorders

Review

作者: Leboyer, Marion ; Bakkar, Ashraf ; Bouillaud, Frederic ; Attal, Romain ; Schwartz, Laurent

Mental and neurodevelopmental disorders are heterogeneous, complex, and overlapping entities. Despite progress, their neurobiological underpinnings are not well understood, and current treatments have limited efficacy. However, a growing number of studies have shown impaired brain and systemic energy metabolism evidenced by low-grade inflammation, metabolic syndrome, mitochondrial dysfunction, and abnormal glucose utilization, although their underlying mechanisms remain poorly understood. This paper reviews metabolic shifts in mental disorders, examines the underlying mechanisms driving these metabolic abnormalities in patient subgroups, and explores targeted therapeutic strategies. We argue here that this inflammation results in hyperosmolarity because of increased protein concentration in the extracellular fluid, resulting from vascular leakages. Hyperosmolarity exerts pressure on the capillaries resulting in altered blood flow (hypoperfusion and/or hyper perfusion). Another consequence of hyperosmolarity is metabolic shifts such as aerobic glycolysis. Hyperosmolarity is also responsible for releasing neurotransmitters such as serotonin, dopamine, glutamate, or gamma-aminobutyric acid (GABA). Drugs known to interfere with metabolism such as methylene blue and lipoic acid have been found to have antidepressant, anxiolytic, and neuroprotective effects (both in animals and in humans) in a large array of mental disorders. We suggest that metabolic shifts are a hallmark of mental disorders and that treatments aiming to alleviate these metabolic shifts may improve patients' prognoses. Mechanisms-based treatments should be tested in future clinical trials, where subgroups of patients characterized as having the most profoundly impaired metabolism should be included, following the rules of precision psychiatry.

107

项与亚甲蓝相关的新闻（医药）

2026-03-26

·EINPresswire

T1Rx Supports Muscle Recovery and Anti-Aging Goals Through Launch of Peptide-Based Therapies

Telehealth Company founded by former U.S. Special Forces offers compounded peptide-based therapies targeting muscle recovery, prescribed by licensed providers. Most men who come to T1Rx have done their research and know peptides. What they don’t know is whether they’re getting is what it claims to be—our pharmacist ensures every compound meets the standard.” — Kris Hasenauer, T1Rx Co-Founder and Former 18D Green Beret VERO BEACH, FL, UNITED STATES, March 26, 2026 / EINPresswire.com / -- T1Rx, a men's health telehealth company founded and operated by former United States Special Forces soldiers who are also licensed medical professionals, today announced the nationwide launch of its compounded peptide therapy protocols. The full-stack offering is available to patients across the country, prescribed through T1Rx's licensed provider network and compounded by Amir Rahemi, a licensed pharmacist and T1Rx co-founder — a credential no other direct competitor in the men's health telehealth space currently holds. In a market increasingly crowded with consumer wellness brands, research-chemical gray markets, and compliance failures, T1Rx enters the peptide space from a position built on operational credibility. Where most telehealth brands source compounded medications through third-party pharmacies, T1Rx has pharmacist-level formulation oversight embedded in its founding team. A Protocol Built for Operational Readiness — Not Trend Adoption T1Rx's peptide protocols are designed for the same population the brand was built around: current and former military, law enforcement, first responders, competitive athletes, and high-consequence professionals who treat physical and cognitive capability as a non-negotiable operational requirement. The launch includes a full-stack protocol covering recovery, body composition, hormonal support, and tissue repair — formulated as a coordinated system rather than a menu of isolated compounds. Each patient protocol is prescribed following a clinical consultation and bloodwork review, ensuring the protocol matches the individual's physiology rather than a generalized template. This is not the T1Rx debut in regulated compounding. The brand has operated compounded testosterone replacement therapy and other hormone protocols nationally since its founding. The peptide launch extends that clinical infrastructure into a space where patient safety risk is highest and where the regulatory gap between compliant and non-compliant operators is widest. The Clinical Differentiator: Pharmacist-Formulated, Not Outsourced Amir Rahemi, T1Rx co-founder and licensed compounding pharmacist, oversees the formulation of every compounded medication T1Rx prescribes. His licensure means T1Rx operates with a level of in-house quality control that telehealth brands relying solely on third-party pharmacy partnerships cannot replicate. The distinction matters in the current regulatory environment. Pharmacy Times and multiple legal and compliance publications have documented the widening divide between licensed compounders operating under USP 797/795 standards and the gray-market operators who have flooded the peptide space. T1Rx compounding is sterile, pharmaceutical-grade, traceable, and overseen by a credentialed pharmacist who answers directly to the patients his protocols serve. For patients who have previously sourced peptides through unregulated online vendors or gray-market suppliers, T1Rx's model represents a transition to clinically governed care — with the same access and convenience of telehealth but none of the sourcing uncertainty. To schedule a consultation or learn more, visit t1rx.com or initiate a live chat directly on the website. Founded Where Others Aren't Qualified to Stand T1Rx was built by Special Forces veterans who spent careers operating in environments where performance degradation is not an inconvenience — it is a liability. That background shapes every protocol the brand offers, including the peptide launch. The clinical question T1Rx asks is not what compound is trending, but what the patient's bloodwork demands and what protocol maintains their readiness over time. The brand's existing service infrastructure spans testosterone replacement therapy, tadalafil protocols, ketamine therapy, and methylene blue — all prescribed and formulated under the same clinical standard. The peptide launch integrates into that infrastructure rather than standing apart from it, allowing T1Rx providers to build coordinated protocols that address multiple systems simultaneously. Availability T1Rx peptide therapy is available nationwide through the T1Rx telehealth platform. The process begins with an initial consultation , followed by a bloodwork review and provider-prescribed protocol. Compounded formulations are shipped directly to the patient. Existing T1Rx patients may request a protocol review to determine whether peptide therapy is appropriate alongside their current regimen. About T1Rx T1Rx - Telehealth company founded by former United States Special Forces soldiers who are also licensed medical professionals. T1Rx owns and operates physician offices, pharmacies, and supplement lines — providing compounded testosterone replacement therapy, tadalafil protocols, ketamine therapy, methylene blue, peptide therapy, and pharmacist-formulated supplements to patients nationwide. Co-founder Amir Rahemi is a licensed compounding pharmacist. Co-founder Kris Hasenauer is a former Special Forces operator and published author. T1Rx exists for people who accept responsibility for remaining capable. T1Rx Communications T1RX +1 877-438-8179 info@t1rx.com Visit us on social media: Instagram Facebook YouTube TikTok X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

2026-03-23

·今日头条

深度好文 | 生物注射剂安慰剂开发：如何科学地实现"完美双盲"？

在生物制药的临床研究中，"随机、双盲、对照"是公认的金标准。然而，对于注射用生物药（尤其是高浓度单抗）而言，实现真正的"双盲"远比想象中困难。生物制药往往具有独特的颜色（如淡黄色、乳白色）和较高的黏度。如果安慰剂仅仅是生理盐水，临床医生或受试者只需一眼或推针瞬间的阻力感，就能轻易"破盲"。这不仅会产生心理暗示偏倚，甚至可能导致昂贵的临床试验宣告失败。近日，发表于 Antibody Therapeutics 的综述性教程文章系统性地总结了注射用生物药配套安慰剂的开发方法论。我们将为您深入解析其中的关键技术逻辑。全文可点击：https://doi.org/10.1093/abt/tbaf009 本文是抗体药制剂专辑的一部分。点击链接查看专辑的全部内容：https://academic.oup.com/abt/pages/formulation-of-antibody-based-therapeutics 一、核心挑战：为什么生物药安慰剂难做？生物大分子药物的理化特性受其高分子量及制剂配方影响，主要挑战集中在三个维度：颜色匹配（蛋白质溶液常因色氨酸氧化、赖氨酸糖化等原因呈现微黄色至棕褐色，且随浓度变化）、黏度匹配（高浓度生物制剂的黏度显著高于纯水，注射过程中的推力感差异是常见的破盲隐患）、以及理化稳定性与稳健性（安慰剂必须在储存、冻融和光照条件下保持物理外观与活性药物同步，不能发生沉淀或变色）。二、科学配色的"黑科技"：颜色去卷积算法论文的核心亮点之一是引入了基于紫外-可见分光光度法（UV-Vis）的颜色去卷积算法（Color Deconvolution Algorithm）。以往的配色依赖人工肉眼观察，主观性极强。该研究提出了一种定量化流程：通过紫外-可见分光光度计扫描样品在 340–830 nm 范围内的吸收光谱，将光谱数据转换至 CIE L*a*b* 色彩空间，再计算两种液体之间的色差值 ΔE 来量化差异。研究引用的文献表明，当 ΔE = 2.3 时，约 13% 的观察者能察觉到颜色差异，因此该值被视为实际应用中的感知阈值。该研究实际测得的色差值远低于此阈值（黄色 ΔE = 1.11，粉色 ΔE = 0.15，棕色 ΔE = 1.03）。着色剂的选择上，研究使用了四种均具有注射用途临床批准记录的试剂：维生素 B2（核黄素，呈黄色）、维生素 B12（氰钴胺，呈粉红色）、亚甲蓝（呈蓝色）以及吲哚菁绿（呈绿色），通过算法将其精准组合以还原目标药物颜色。图1工作流程图图2 颜色对比图三、黏度调节：平衡"手感"与稳定性为了模拟高浓度蛋白溶液的黏度，研究重点解析了羧甲基纤维素钠（Na-CMC) 的应用。黏度调节并非简单的线性关系——离子强度（如 NaCl 浓度）会显著影响 Na-CMC 的聚合物链舒展，从而降低黏度；而制剂中常用的蔗糖则会产生协同增稠作用。研究采用固定剪切速率（30 s⁻¹）测量黏度，以模拟皮下注射时的实际操作条件，确保安慰剂的**推力（Glide Force）**与药物完全匹配。值得注意的是，研究还发现着色剂本身会通过氢键或疏水相互作用降低 Na-CMC 的黏度，具体机制因着色剂种类及缓冲液体系而异。四、严苛的稳健性验证（Robustness Testing）一个合格的安慰剂不仅要"现在像"，还要"一直像"。论文对安慰剂配方进行了全方位的稳健性压力测试：冻融稳健性（经历五次冻融循环后，颜色、pH 及渗透压均无显著变化）、热稳健性（在 25°C/60% 相对湿度条件下储存一个月，与 2–8°C 对照组相比，各项指标保持稳定，仅高黏度样品出现轻微黏度下降）、以及渗透压与 pH 匹配（安慰剂的渗透压须与药物保持一致，以避免注射时的局部疼痛差异）。五、结论与实操指南该论文为行业提供了一套标准化开发工作流，核心在于将稳健性贯穿于整个开发周期：特性表征 → 基质选择 → 算法配色 → 全面复核。在生物药研发日益精密化的今天，安慰剂开发不应是事后的"补救"，而应作为药物开发整体策略的一部分。这种基于数据驱动的方法，不仅提升了临床双盲的可靠性，也为全球监管机构的合规性审查提供了科学依据。期刊简介《Antibody Therapeutics》是华人抗体协会（ChAbS）的旗下期刊，由牛津大学出版社（Oxford University Press）出版。作为一本同行评审的开放获取期刊，Antibody Therapeutics 为全球科学界提供了一个平台，用于发表治疗性抗体在发现、研究、开发及相关方法学方面的最新进展与挑战。该期刊已被ESCI（影响因子=4.5）、Scopus（CiteScore=8.4）及PubMed Central等主要文献数据库收录。期刊官网：https://academic.oup.com/abt 声明：此文中文版系根据《Antibody Therapeutics》上发表的英文原文论文利用AI工具协助完成。中文作者：黄昊龙中文校阅：史东辉中文编辑：那慧敏

2026-03-21

·Drug递送前沿观察记

口服药物递送系统系列2：小肠靶向与跨上皮转运核心路径

口服药物递送系统的核心使命，是突破胃肠道的多重生理屏障，让药物精准抵达吸收部位并高效转运进入体循环。小肠作为药物吸收的“黄金区域”，凭借巨大的表面积、丰富的血管网络和相对温和的生理环境，成为口服药物递送的核心靶点。然而，小肠黏膜的黏液屏障、紧密连接的上皮细胞层仍为药物转运设置了关键障碍。本期将聚焦小肠靶向与跨上皮转运的核心递送途径，结合最新研究成果与权威文献，系统解析其作用机制、材料应用及前沿进展，为精准解锁小肠吸收“主战场”提供技术蓝图。1. pH响应递送：依托酸碱差异实现小肠精准释药 pH响应递送是小肠靶向最成熟的经典策略，核心原理是利用胃与小肠的显著酸碱差异，设计“胃酸稳定、肠液响应”的肠溶载体，确保药物穿越胃部时不降解，仅在小肠内特异性释放。该策略尤其适用于胰岛素、抗体等酸不稳定生物药，以及需避免胃部刺激的药物。其关键在于选择合适的pH响应材料，这类材料在酸性环境中分子链紧密蜷缩，保持结构稳定；进入小肠中性/弱碱性环境后，发生质子化/去质子化转变，分子链舒展溶胀或溶解，释放包裹的药物。常用材料包括Eudragit®系列聚合物（如Eudragit L100在pH>6.0溶解、Eudragit S100在pH>7.0溶解）、海藻酸钙、羧甲基-κ-卡拉胶等，可通过材料组合精准调节载体的响应pH阈值。为解决胰岛素口服递送难题，研究人员设计了海藻酸钠-壳聚糖复合pH响应微球载体，其外层包覆Eudragit L100，在模拟胃液中浸泡2小时后仍保持结构完整，胰岛素保留率达92%；进入模拟小肠液后，外层包衣快速溶解，微球溶胀释放胰岛素，24小时累积释放率达85%。动物实验证实，该制剂口服后能显著降低糖尿病小鼠血糖水平，生物利用度较传统口服制剂提升3.2倍。另一项研究优化了pH响应载体的制备工艺，通过喷雾干燥技术制备了负载阿魏酸的Eudragit® L100微球制剂，系统优化处方参数以提升载体的肠溶性能与载药稳定性。该制剂依托Eudragit® L100在pH>6.0溶解的特性，在模拟胃液（pH 1.2）中滞留2小时仅释放少量阿魏酸（释放率<8%），有效避免药物在胃内降解；进入模拟小肠液（pH 6.8）后，微球快速溶胀释药，5小时累积释放率达92%以上，实现阿魏酸在小肠的精准靶向释放，同时依托微球的缓释特性延长药物在小肠的吸收时间，提升生物利用度，且体外细胞实验证实该制剂具有良好的细胞保护作用。除上述研究外，一项研究报道了一种新型pH/活性氧（ROS）双响应果胶基水凝胶材料，为小肠靶向递送提供了新选择。该材料通过席夫碱反应，将氨基酸修饰的聚合物胶束与氧化果胶（OP）动态交联，构建出Lys-PA-SS-OA/OP水凝胶，具有优异的pH响应特性——在模拟胃液中保持结构稳定，在小肠中性环境中发生溶胶-凝胶相变，实现药物梯度控释，48小时内累积释放率超过60%，且无显著细胞毒性，尤其适用于慢性炎症性疾病相关药物的小肠靶向递送，是近年来新型pH响应材料的典型代表。同时，2024年获批上市的亚甲蓝肠溶缓释片（商品名：莱芙兰®），作为pH响应型小肠靶向制剂的临床典型代表，其核心递送技术依赖多基质（MMXTM）专利肠溶技术，该技术由欧洲制药企业研发，专门针对肠道靶向释药优化设计，具体而言，该制剂为多层结构设计，外层为肠溶包衣层，可在模拟胃液中持续稳定2小时以上，避免亚甲蓝在胃部释放引发刺激或降解；中层为缓释基质层，进入小肠环境后，外层包衣快速溶解，中层基质通过溶胀、扩散作用实现亚甲蓝的缓慢缓释，确保药物在小肠内停留期间持续释放，提升生物利用度；内层为药物核心层，有效保证药物纯度与稳定性。该制剂的核心适应症为“在接受结肠镜检查筛查或监测的成人患者中增强结直肠病变的可视化”，可显著提高非息肉样结直肠病变检出率。临床研究数据显示，其口服后能在小肠内精准释药，血药浓度峰值平稳，可显著增强结直肠病变的可视化效果，辅助提高组织学证实的非息肉样结直肠病变的检出率，间接降低结直肠癌的病死率，不良反应发生率显著低于传统制剂。图片来源：国家医疗保障局2. 胃肠道合成上皮衬里（GSEL）：小肠表面的“原位靶向涂层” GSEL是一种创新的小肠靶向策略，打破了传统载体“被动转运”的局限，通过在小肠上皮表面原位形成功能性涂层，实现药物的精准锚定与控释。其核心优势在于主动适配小肠生理环境，显著提升载体与小肠黏膜的结合稳定性，延长药物驻留时间。一项研究中利用小肠上皮细胞内高表达的过氧化氢酶（CAT），实现小肠靶向的原位聚合涂层形成。将多巴胺单体与低浓度过氧化氢共溶于Tris缓冲液，口服后该溶液可顺利通过胃环境，在小肠内触发反应。小肠上皮细胞内的过氧化氢酶会催化过氧化氢分解产生氧气，使多巴胺单体在缺氧的肠道环境中快速聚合，形成致密的聚多巴胺（PDA）衬里，药物被锚定在衬里中实现持续释放。图片来源 Li J, Wang T, Kirtane AR, et al. Gastrointestinal synthetic epithelial linings[J]. Science Translational Medicine, 2020, 12(558): abc0441. 突破胃肠屏障-口服药物递送系统（ODDSs）的设计原理与前沿进展该研究在猪小肠离体组织与在体实验中验证了技术有效性：离体实验中，PDA涂层在12分钟内即可完成形成，且仅特异性沉积于小肠黏膜侧（十二指肠、空肠涂层信号最强），食管、胃黏膜无明显涂层；在体实验中，通过内镜给药后，PDA衬里在小肠内稳定驻留超8小时，24小时内可完全脱落，无肠道粘连或炎症反应。研究将吡喹酮（疏水性药物）作为模型药物，证实GSEL技术可显著延长药物肠道滞留时间，药物半衰期从1.3小时延长至13小时，血药浓度在24小时后仍维持在20.0 ng/ml，生物利用度（AUC）较传统制剂提升4倍，充分体现了其在药物控释递送中的优势。另一项研究进一步优化了GSEL的生物相容性，采用酪胺替代部分多巴胺作为聚合单体，降低了聚多巴胺的细胞毒性。该改良系统在小型猪体内实现了长达12小时的小肠黏膜锚定，成功递送胰岛素后，猪的血糖水平在2-8小时内维持在正常范围，证实了GSEL技术在大型动物中的可行性与安全性。3. 细胞旁路转运：打开上皮细胞间的“通道之门” 细胞旁路转运是药物跨上皮转运的重要途径之一，核心原理是通过渗透促进剂暂时、可逆地打开肠上皮细胞间的“紧密连接”，使药物从细胞间隙穿过屏障进入血液循环。该策略尤其适用于水溶性小分子药物和部分大分子药物，无需依赖细胞内吞作用，转运效率高且不易引发药物降解。紧密连接是肠上皮细胞间的“密封装置”，由闭合蛋白、咬合蛋白等构成，正常状态下仅允许水分子和小分子电解质通过。细胞旁路转运的关键是选择安全有效的渗透促进剂，这类物质需能与紧密连接相关蛋白结合或改变细胞膜脂质结构，实现紧密连接的可逆开放，且在停药后能快速恢复正常，避免长期肠道屏障功能损伤。常用的渗透促进剂包括壳聚糖（天然阳离子多糖）、癸酸钠（脂肪酸类）、EDTA（螯合剂）等。在细胞旁路转运的临床应用中，SNAC介导口服司美格鲁肽递送是典型范例，其成功突破了口服多肽的胃肠道屏障瓶颈，推动了口服多肽药物的发展。口服多肽的递送核心难点的是胃酸降解、肠道酶解及肠上皮紧密连接的物理阻碍，而SNAC作为特异性渗透促进剂，可通过多重作用实现司美格鲁肽的小肠细胞旁路高效转运。具体而言，SNAC作为脂肪酸类渗透促进剂，可通过非共价键与司美格鲁肽分子临时结合，一方面在胃部局部中和胃酸，构建短暂的碱性微环境，抑制胃蛋白酶活性，保护司美格鲁肽免受胃酸与酶解损伤，确保药物顺利抵达小肠吸收部位；另一方面，SNAC可改变小肠肠上皮细胞膜的脂质流动性，暂时、可逆地打开肠上皮细胞间的紧密连接，为司美格鲁肽提供细胞间隙的转运通道，促进药物从细胞旁路穿越肠黏膜屏障进入体循环，实现高效吸收。除SNAC外，天然阳离子多糖壳聚糖单独应用也能有效介导小肠细胞旁路转运，尤其适用于水溶性小分子药物的递送。壳聚糖可通过其阳离子基团与肠上皮细胞紧密连接的阴离子闭合蛋白发生静电结合，使紧密连接开放程度提升35%-50%，且该开放具有可逆性，停药24小时后肠道紧密连接可完全恢复正常，无黏膜损伤风险。以水溶性药物5-氟尿嘧啶（抗肿瘤药物）为模型药物，研究显示，壳聚糖修饰的5-氟尿嘧啶口服制剂，在Caco-2细胞单层模型中药物表观渗透系数（Papp）较对照组提升3.1倍；小鼠体内实验证实，该制剂口服后血药浓度峰值提升2.2倍，生物利用度提升89%。4. 跨细胞转运增强策略：精准介导的“细胞内穿梭” 跨细胞转运是大分子药物（如抗体、多肽、核酸）穿越肠上皮屏障的主要途径，核心原理是药物被肠上皮细胞通过内吞作用摄取，穿过细胞后释放到细胞间质，进而进入血液循环。通过在载体表面修饰特异性配体，可实现跨细胞转运的精准介导，显著提高药物的摄取效率与靶向性，降低非特异性吸收带来的副作用。跨细胞转运的关键在于配体-受体的特异性识别，常用配体包括转铁蛋白、叶酸、甘露糖、RGD肽等，这些配体可与肠上皮细胞表面高表达的相应受体结合，通过网格蛋白介导的内吞、小窝蛋白介导的内吞等途径进入细胞。载体进入细胞后，需能从内吞体中逃逸，避免被溶酶体降解，最终在细胞内或细胞间质释放药物，完成跨细胞转运。聚乳酸-羟基乙酸共聚物（PLGA）作为生物相容性与降解性俱佳的聚合物材料，在跨细胞转运载体中应用广泛，其可通过调控聚乳酸（PLA）与聚乙醇酸（PGA）的比例，实现降解速率与药物释放动力学的精准调控，尤其适合包载溶解性与通透性较差的药物分子。而聚乙二醇（PEG）修饰（PEGylation）是提升PLGA纳米载体跨细胞转运效率的关键策略，通过在载体表面形成PEG冠状结构，可显著降低网状内皮系统的调理作用与免疫系统识别，减少载体与小肠黏液层的非特异性吸附，延长载体在肠道内的驻留时间。研究开发了转铁蛋白修饰的PEG化PLGA纳米载体，用于口服递送单克隆抗体。该载体通过转铁蛋白与肠上皮细胞表面转铁蛋白受体的特异性结合，被高效内吞进入细胞，内吞效率较未修饰载体提升4.2倍；同时，载体表面修饰的pH敏感聚合物可帮助其从内吞体逃逸，避免抗体被溶酶体降解。小鼠体内实验显示，该制剂口服后抗体的生物利用度达18.7%，较传统口服制剂提升近10倍，且能有效靶向结合体内抗原，发挥治疗作用。5. M细胞相关途径：黏膜免疫的“精准导航系统” M细胞（Microfold Cell）是分布在肠道派尔集合淋巴结和孤立淋巴滤泡表面的特殊上皮细胞，具有极强的抗原摄取和转运能力，是黏膜免疫反应的“启动器”。M细胞相关途径通过靶向M细胞表面特异性标志物，将药物或疫苗递送至黏膜免疫系统，尤其适用于口服疫苗、免疫调节剂的递送，可同时激发体液免疫、细胞免疫和黏膜免疫，显著提升免疫效果。 M细胞的靶向策略主要基于其表面高表达的特异性受体，如GP2受体、β1整合素、凝集素受体等，通过在载体表面修饰相应配体（如RGD肽、凝集素、抗GP2抗体），可实现载体与M细胞的特异性结合，促进M细胞对载体的内吞与转运。与普通肠上皮细胞不同，M细胞内吞的物质可快速转运至下方的免疫细胞（如巨噬细胞、树突状细胞），引发免疫反应或被进一步转运至体循环。在M细胞GP2受体靶向的口服疫苗递送中，PEG-PCL纳米载体展现出优异的应用潜力，研究采用抗GP2单链抗体修饰PEG-PCL纳米载体，装载结核分枝杆菌ESAT-6/CFP-10融合抗原，构建出精准靶向M细胞的口服疫苗递送系统，实验数据表明，经修饰后的纳米载体与M细胞的特异性结合率较未修饰载体提升6.1倍，内吞效率提升5.3倍；小鼠体内实验显示，口服该疫苗后，肠道黏膜分泌型IgA抗体水平较对照组升高3.7倍，血清中特异性IgG抗体滴度与皮下注射组无显著差异（P>0.05），脾脏淋巴细胞增殖指数提升2.9倍，对结核分枝杆菌H37Rv菌株感染的保护率达75%。除GP2受体靶向策略外，凝集素（UEA-1）修饰的脂质体载体也可实现M细胞精准靶向，该载体以乙肝表面抗原（HBsAg）为模型疫苗，依托UEA-1与M细胞表面凝集素受体的特异性结合，快速被M细胞摄取并递送至肠道派尔集合淋巴结的抗原呈递细胞。小鼠口服免疫实验证实，该制剂可显著升高体内特异性抗HBsAg IgG抗体滴度，使黏膜分泌型IgA抗体水平提升4.8倍，免疫保护期长达6个月，且载体生物相容性良好，未引发肠道黏膜炎症反应。参考文献 1. Li J, Zhang H, Wang L, et al. Alginate-chitosan composite microspheres coated with Eudragit L100 for oral insulin delivery[J]. International Journal of Pharmaceutics, 589: 120438. 2. Spray-dried Eudragit® L100 microparticles containing ferulic acid: Formulation, in vitro cytoprotection and in vivo anti-platelet effect[J]. Pharmaceutics, 16(8): 1193. 3. Li J, Wang T, Kirtane AR, et al. Gastrointestinal synthetic epithelial linings[J]. Science Translational Medicine, 12(558): abc0441. 链接：https://pmc.ncbi.nlm.nih.gov/articles/PMC8221077/ 4. Li J, Wang T, Kirtane AR, et al. Gastrointestinal synthetic epithelial linings[J]. Science Translational Medicine, 12(558): abc0441. 5. A new era for oral peptides: SNAC and the development of oral semaglutide for the treatment of type 2 diabetes[J]. Journal of Controlled Release, 323: 188-200. 6. Ahmed S, Ali J, Khan M, et al. Chitosan as a paracellular penetration enhancer for oral delivery of 5-fluorouracil: In vitro and in vivo evaluation[J]. Journal of Pharmaceutical Sciences, 2023, 112(4): 987-998. 7. Kesharwani P, Kumar V, Goh KW, et al. PEGylated PLGA nanoparticles: unlocking advanced strategies for cancer therapy[J]. Journal of Translational Medicine, 23(1): 241. 8. Chen L, Zhang Z, Li M, et al. Mannose-modified chitosan nanogels for oral influenza vaccine delivery[J]. ACS Nano, 2024, 18(3): 2789-2802. 9. Yang C, Liu X, Zhang W, et al. GP2-targeted PEG-PCL nanoparticles enhance oral vaccine delivery against Mycobacterium tuberculosis by promoting M cell transcytosis[J]. Journal of Nanobiotechnology, 2024, 22(1): 156. 10. El-Sayed Y, El-Bashiti E, El-Sherbiny I, et al. Ulex europaeus agglutinin 1-conjugated liposomes for M cell-targeted oral delivery of hepatitis B surface antigen[J]. Colloids and Surfaces B: Biointerfaces, 2010, 81(1): 189-196. 13. Conzer Pharma. Methylene Blue Enteric Sustained-Release Tablets Approved for Marketing in China[EB/OL]. 来源：每日经济新闻. 14. National Medical Products Administration. Drug Approval Document Delivery Information on June 18, 2024[EB/OL]. 2024-06-18. 15. China Pharmaceutical News. Methylene Blue Enteric Sustained-Release Tablets: An Innovative Oral Drug, a Powerful Assistant for Colonoscopy[EB/OL].

100 项与亚甲蓝相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D02312	亚甲蓝	V04CG05 V03AB17	DB09241

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适应症	国家/地区	公司	日期
结直肠癌	中国	Alfasigma SpA	2024-06-11
结直肠癌	中国	深圳市康哲药业有限公司	2024-06-11
诊断试剂	欧盟	Cosmo Technologies Ltd.	2020-08-19
诊断试剂	冰岛	Cosmo Technologies Ltd.	2020-08-19
诊断试剂	列支敦士登	Cosmo Technologies Ltd.	2020-08-19
诊断试剂	挪威	Cosmo Technologies Ltd.	2020-08-19
高铁血红蛋白血症	欧盟	Provepharm SAS	2011-05-06
高铁血红蛋白血症	冰岛	Provepharm SAS	2011-05-06
高铁血红蛋白血症	列支敦士登	Provepharm SAS	2011-05-06
高铁血红蛋白血症	挪威	Provepharm SAS	2011-05-06
细菌感染	-	-	2011-01-01
中毒	中国	济川药业集团有限公司	-

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适应症	最高研发状态	国家/地区	公司	日期
可见病灶	申请上市	加拿大	PharmaSciences, Inc.	2021-12-22
皮肤鳞状细胞癌	临床3期	伊朗	Mashhad University of Medical Sciences	2025-12-20
基底细胞癌	临床3期	伊朗	Mashhad University of Medical Sciences	2025-10-21
胃肠道疾病	临床3期	美国	Cosmo Pharmaceuticals NV	-
脓毒性休克	临床2期	美国	Provepharm Life Solutions SA	2019-12-01
原位癌	临床2期	意大利	Cosmo Technologies Ltd.	2012-01-09
溃疡性结肠炎	临床2期	意大利	Cosmo Technologies Ltd.	2012-01-09
结肠癌	临床2期	意大利	Cosmo Technologies Ltd.	2012-01-09
结肠疾病	临床2期	-	Cosmo Technologies Ltd.	2011-05-02
阿尔茨海默症	临床2期	-	TauRx Therapeutics Ltd.	2004-08-01

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02478281 (CTgov)	临床1期	先天性高铁血红蛋白血症	12	Methylene Blue	廠選鏇齋艱範鹹壓淵網(網觸壓願選鹽簾夢網鹽) = 壓餘願齋鹹窪選製觸襯壓餘繭糧膚範壓選鏇膚 (鏇繭壓簾憲夢範鹽艱憲, 40.3)	-	2025-06-05
ASCO2025	N/A	乳腺癌	28	Gentian violet	獵鬱鬱繭鏇鹹範簾膚鬱(膚製築遞窪餘顧憲積憲) = 膚壓廠艱餘鹹鏇鏇鑰窪繭餘襯膚構廠壓鏇鏇蓋 (選選鏇製廠繭壓蓋顧築 ) 更多	积极	2025-05-30
NCT06284941 (CTgov)	N/A	镇痛	90	ropivacaine (0.25% Ropivacaine 30ml for Iliac Fascia Block)	簾鹹製糧鏇夢壓觸鏇壓(顧築鬱觸選範顧醖廠獵) = 築鏇鏇齋壓衊獵鏇構鏇淵鹹構願齋觸鑰憲鹽鬱 (艱夢鹹夢壓鹹製鏇顧遞, 簾壓鏇憲繭糧願衊衊壓 ~ 壓夢淵艱襯窪淵齋顧鹹) 更多	-	2025-02-04
				Ropivacaine combined+methylene blue for iliac fascia block (0.25% Ropivacaine+0.05% Methylene Blue 30ml for Iliac Fascia Block)	簾鹹製糧鏇夢壓觸鏇壓(顧築鬱觸選範顧醖廠獵) = 衊簾網願糧糧鏇醖製獵淵鹹構願齋觸鑰憲鹽鬱 (艱夢鹹夢壓鹹製鏇顧遞, 願夢糧範築鹽獵鬱鹹夢 ~ 夢獵憲鬱範鹹襯窪顧築) 更多
NCT06005558 (Pubmed \| BMC Anesthesiol)	临床2/3期	肿瘤 \| 脓毒性休克	90	Placebo	淵鹽膚築糧鬱糧醖糧襯(齋繭鹹選壓蓋鏇艱鹽願): HR = 0.29 (95% CI, 0.09 ~ 0.9)	积极	2025-01-08
				Methylene Blue 4 mg/kg
NCT02380573 (MB2, CTgov)	临床2期	阿尔茨海默症 \| 轻度认知障碍	117	Methylene Blue+Phenazopyridine hydrochloride (Healthy Aging MB)	製築遞蓋築範膚築夢選(網顧膚鏇選齋憲餘淵鬱) = 齋願窪積衊糧鑰願齋淵鹹糧構鹹齋築襯醖糧製 (鏇鏇構餘遞餘窪鏇淵窪, 2428.23) 更多	-	2024-09-19
				FD&C Blue # 2+Phenazopyridine hydrochloride (Healthy Aging Placebo)	製築遞蓋築範膚築夢選(網顧膚鏇選齋憲餘淵鬱) = 觸願夢選齋遞範網積艱鹹糧構鹹齋築襯醖糧製 (鏇鏇構餘遞餘窪鏇淵窪, 1343.81) 更多
NCT04187053 (CTgov)	临床4期	炎症 \| 化脓 \| Dent病 ... 更多	56	Conventional mechanical therapy+Methylene Blue (Conventional Mechanical Therapy With aPDT Adjunct)	鹹範願壓鏇鹹醖廠糧選(膚遞製選網鏇鹹蓋齋醖) = 夢蓋蓋窪願願廠蓋鹽夢鏇夢窪繭繭構壓簾糧夢 (獵糧積餘遞糧顧憲觸齋, 0.49) 更多	-	2023-12-29
				Conventional mechanical therapy+Saline (Conventional Mechanical Therapy With Sham aPDT Treatment)	鹹範願壓鏇鹹醖廠糧選(膚遞製選網鏇鹹蓋齋醖) = 夢鬱齋簾願簾鑰襯餘鬱鏇夢窪繭繭構壓簾糧夢 (獵糧積餘遞糧顧憲觸齋, 0.70) 更多
NCT03395223 (MEBIPAM, CTgov)	临床4期	获得性高铁血红蛋白血症	7	Methylene Blue	鹽廠鑰鬱鹽簾顧構齋鬱 = 憲衊廠憲鹽糧艱繭餘廠觸鏇蓋壓範廠積繭獵糧 (鹽製淵糧鑰構簾憲鬱獵, 簾襯鬱顧蓋繭壓願齋窪 ~ 淵觸顧餘鏇齋艱艱醖鹹) 更多	-	2023-04-10
NCT04446871 (Pubmed \| Crit Care)	临床2/3期	脓毒性休克	91	Methylene blue	窪蓋製夢鏇鏇鹹鹽遞鬱(憲窪簾衊觸艱願衊鹽餘) = 廠廠襯願醖蓋構餘糧窪餘顧衊網艱餘網選網憲 (襯鑰窪積蓋艱夢鏇膚構 )	-	2023-03-13
NCT01386879 (CTgov)	临床4期	-	50	Methylene Blue (TaperGuard Evac ETT)	遞製顧繭蓋窪製壓觸鏇 = 範蓋觸夢選鏇簾網獵鹹齋鹽顧衊構選壓選範願 (憲淵淵積積築簾網遞鏇, 獵憲遞願淵構鑰鏇範膚 ~ 餘鹽積醖餘簾遞廠顧簾) 更多	-	2022-06-08
				Methylene Blue (Teleflex ISIS ETT)	遞製顧繭蓋窪製壓觸鏇 = 壓網繭衊憲壓窪窪繭製齋鹽顧衊構選壓選範願 (憲淵淵積積築簾網遞鏇, 簾艱鹹製淵鑰鹽積夢繭 ~ 廠糧衊醖淵鹹鏇製範餘) 更多
NCT02851108 (BlueACTn, CTgov)	临床2期	恶性疟	100	Methylene Blue (AS-AQ-MB)	衊遞選築餘齋壓獵襯願(鹹選夢鹹廠築鏇鹹艱醖) = 選齋淵夢鑰醖鬱願積鑰鑰遞襯糧襯網遞積糧構 (願醖鹽鹹製簾製願繭窪, 1.42) 更多	-	2020-03-25
				Primaquine (AS-AQ-PQ)	衊遞選築餘齋壓獵襯願(鹹選夢鹹廠築鏇鹹艱醖) = 顧鬱鑰選觸餘艱願積繭鑰遞襯糧襯網遞積糧構 (願醖鹽鹹製簾製願繭窪, 0.94) 更多