Efficacy of Oral or Topical Catechins vs. Placebo as an Adjuvant for the Prevention and Management of Radiation Dermatitis in Oncology Patients: a Randomized Trial

Introduction Radiation-induced dermatitis (RID), which includes both acute and chronic forms, affects up to 95% of patients undergoing radiation therapy. Despite its high incidence, there are currently no validated prevention and management recommendations specifically for the mexican population. Catechins, particularly epigallocatechin gallate and epicatechin, are emerging as a promising and readily accessible therapeutic option for radiation damage in skin and other organs, including conditions like esophagitis, intestinal injury, and mucositis.
Objective This study aims to evaluate the utility of oral or topical catechins in preventing and managing acute and chronic radiation-induced dermatitis in cancer patients, comparing their effectiveness against standard treatment.
Material and Methods
This will be a randomized, double-blind, phase III clinical trial with a longitudinal and comparative design. Patients will be allocated into two primary study groups: prevention (n=81) and treatment (n=81). Each group will be further divided into four treatment arms:
Epigallocatechin gallate (experimental aerosol)
Epicatechin (experimental capsule)
Saline control arm (aerosol)
Microcrystalline cellulose excipient control arm (capsule)
All participants across all groups will receive standard care. Study endpoints will include the assessment of utility, toxicity, quality of life, and cosmesis, using various validated scales and scores.
Ethics This study adheres to the principles outlined in the Helsinki Declaration (2024), the Nuremberg Code, and Mexico's General Health Law on health research. Given the wide therapeutic margin of the interventions, the study is classified as minimal risk.
Statistical Analysis To evaluate the efficacy of the intervention (specifically, the change in the risk of dermatitis and fibrosis), we will calculate the hazard ratio using Cox regression and compare it with the Log-Rank test. Additionally, both fixed and random effects models will be performed and compared using the likelihood ratio test.

开始日期2025-09-01

申办/合作机构

Universidad de Guanajuato

[+2]

CTRI/2025/04/085327

/ Not yet recruiting临床4期IIT

One-year Comparative evaluation of effect of emblica officinalis, Epigallactocatechin-3-gallate, chlorhexidine using selective etch technique on clinical performance of composite resin restoration in cases of Non carious cervical lesions: A randomized clinical study - NIL

开始日期2025-05-15

申办/合作机构-

TCTR20250317007

/ Not yet recruiting临床1期IIT

Skin Evaluation of Turmeric/EGCG Emulgel for Skin Irritation and Sensitization Effects in Healthy Participants

开始日期2025-05-01

申办/合作机构

Chiang Mai University

100 项与表没食子儿茶素没食子酸酯相关的临床结果

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100 项与表没食子儿茶素没食子酸酯相关的转化医学

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100 项与表没食子儿茶素没食子酸酯相关的专利（医药）

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16,190

项与表没食子儿茶素没食子酸酯相关的文献（医药）

2026-02-01·BIOMATERIALS

EGCG-releasing nanofibrous scaffold enhances wound healing via γδ T cells modulation

Article

作者: Qu, Yili ; Xu, Zhaoyu ; Yang, Xingmei ; An, Tiantian ; Li, Xinhui ; Chen, Shuaidong ; Yang, Yang ; Man, Yi ; Hu, Chen

This study investigates the role of γδ T cells in wound healing facilitated by an EGCG (Epigallocatechin gallate)-releasing nanofibrous scaffold with aligned topography (APEMS). Incorporating core-shell microcapsules for sustained EGCG release over 11 days, the biocompatible scaffold enhances γδ T cell activity to promote advanced wound repair. In a splinted wound excisional model in 6-8 weeks-old male C57BL/6J mice, APEMS significantly improved re-epithelialization and wound closure compared to a control scaffold (APS). Single-cell RNA sequencing revealed a marked increase in γδ T cell in the APEMS group, where γδ T cells accounted for 66.2 % of the T cell population, compared to 33.8 % in the APS group. Cellchat analysis identified the AREG-EGFR signaling axis as pivotal to γδ T cell-mediated wound repair. APEMS-induced γδ T cells secreted amphiregulin (AREG), which acted on keratinocytes and fibroblasts to enhance keratinocyte proliferation, migration, and fibroblast-driven extracellular matrix remodeling. In immunodeficient mice lacking mature γδ T cells (TCRδ-/-), wound healing was significantly impaired, characterized by delayed re-epithelialization, reduced neo-dermal thickness, and increased inflammation. Inhibition of AREG and EGFR function via monoclonal antibodies against AREG and EGFR antagonist Gefitinib similarly delayed wound healing, the therapeutic advantage of APEMS over APS was abolished, emphasizing its critical role in the process. These findings provide a framework for developing advanced wound management materials and highlight the therapeutic potential of targeting γδ T cells and AREG-EGFR signaling to enhance tissue regeneration.

2026-02-01·BIOMATERIALS

Self-adaptive covalent coating for vascular stents: Coordinated coagulation-inflammation regulation to support re-endothelialization for atherosclerosis control

Article

作者: Xiao, Yun ; Zhang, Wenbin ; Wang, Yanan ; Chen, Zhezhe ; Luo, Rifang ; Ma, Boxuan ; Zhu, Qiongjun ; Wang, Yao ; Fu, Guosheng ; Wang, Xiaoyu ; Wang, Yunbing

Therapeutic-coated vascular stents are one of the key directions in the clinical treatment of atherosclerosis. However, vascular injury and implant stimulation trigger a feedback loop between coagulation and inflammation, impairing endothelial cell (EC) function, which is critical for long-term success in atherosclerotic vessels. Here, we designed a self-adaptive covalent coating stent that integrates thrombin-responsive release of apixaban as a coagulation modulator and an antioxidant polyphenol as an anti-inflammatory. This pathologic microenvironment-responsive coating regulates coagulation-inflammation loop post-implantation. The nanogels within the coating dynamically response to thrombin, the upstream initiator of coagulation-inflammation, to release apixaban in high thrombotic risk conditions while retaining it in low-risk states. Epigallocatechin gallate (EGCG), functioning as a cross-linker and the ROS scavagener, detaches in response to oxidative stress. As such, the coating enables blockade of coagulation-inflammation loop, synergistically protects ECs from inflammatory damage, promotes endothelial regeneration, and inhibits endothelial-to-mesenchymal transition (EndMT), efficiently modulating the inflammatory microenvironment via localized and coordinated regulation of coagulation-inflammation loop. Furthermore, the implantation in an atherosclerotic rabbit model demonstrated that the coating inhibits plaque deterioration linked to inflammation and endothelial damage. This dual-responsive strategy offers a promising avenue for therapeutic stents by mitigating the coagulation-inflammation loop and supporting endothelial repair in atherosclerotic vessels.

2026-02-01·JOURNAL OF COLLOID AND INTERFACE SCIENCE

Near-infrared and pH dual-responsive chitosan/epigallocatechin gallate/hollow CuS hydrogel reprograms ROS dynamics for infected wound healing

Article

作者: Yang, Junhong ; Zhao, Shuang ; Yang, Pami ; Zeng, Qin ; Zhang, Yi ; Deng, Chunyan ; Wu, Wuming ; Yin, Ke ; Liu, Yuancheng

Bacterial-infected wounds pose a clinical challenge requiring innovative strategies integrating precise antibacterial action and microenvironment reprogramming. To address this, a multifunctional H-CuS NPs@epigallocatechin gallate (EGCG)/chitosan (CS)/3-formylphenylboronic acid (3-FPBA) hydrogel (H-CuS@EGCG HY) was engineered. This hydrogel exhibits injectability, self-healing, tissue adhesion, and pH-responsive behavior. During the initial phase of wound infection (weakly acidic microenvironment), this network undergoes controlled dissociation, enabling on-demand localized release of EGCG and Cu^1+/2+. Under near-infrared (NIR) irradiation, the photothermal effect of H-CuS NPs promotes mild heating, which enhances EGCG/Cu^1+/2+ release and penetration. The released Cu^1+/2+ further catalyzes •OH generation from H₂O₂ via Fenton reaction, synergizing with EGCG and photothermal therapy to improve antibacterial efficacy. Additionally, EGCG scavenges excess radicals, reducing oxidative stress and inflammation, while Cu^1+/2+ supports angiogenesis via VEGF regulation-collectively reprogramming the wound microenvironment. In vitro tests showed broad-spectrum antimicrobial activity with a 99 % eradication rate. In S. aureus-infected mouse models, compared to the control group, the H-CuS@EGCG HY + NIR group significantly reduced the levels of inflammatory cytokines (TNF-α), promoted the expression of CD31 and CD206, and effectively modulated the wound microenvironment, ultimately resulting in complete wound closure (100 %) by day 13, accompanied by full epidermal regeneration and minimal scarring. This study provides a promising strategy for the treatment of clinical wounds.

项与表没食子儿茶素没食子酸酯相关的新闻（医药）

2025-09-13

·生物谷

想补脑子？试试维生素B+绿茶！多项研究：联用显著延缓神经衰老，经常补充不仅痴呆风险骤降超60%，还能有效降血压

他坐在藤椅里，看云影掠过窗棂。那些被唤作“记忆”的星屑，仿佛从时光琥珀的裂隙中一粒一粒，飘向宇宙的深寂——一如脑海中的过往，在不动声色中逐渐淡去。随着人口老龄化的加速，这样的“记忆流失”不再只是诗意的隐喻，而是真切发生在无数家庭中的现实。神经退行性疾病的流行率正在显著上升，而其中，阿尔茨海默病（AD）是最常见的一种。《中国阿尔茨海默病报告2024》[1]指出，截至2021年，我国AD及其他痴呆患者已达1699.0827万人，患病率为1194.2/10万，死亡率为34.6/10万，这不仅是一组沉重的数字，更是一段段逐渐消散的亲情、认知与自我认同。但研究者们正在时间的缝隙中寻找新的“记忆修复剂”。近期发表在GeroScience的一项研究[2]发现，仅仅用烟酰胺（维生素B3）或EGCG（绿茶中的抗氧化剂——儿茶素）单独处理老年神经元16小时，就能显著提升鸟苷三磷酸（GTP）能量水平，接近年轻神经元的状态；而将两者联合使用，甚至能将GTP恢复到“完全年轻化”的水平。这种代谢干预不仅修复了囊泡运输与自噬功能，还显著减少了Aβ聚集与蛋白质氧化损伤，为延缓神经衰老、干预AD开辟了一条潜在的新路径。 GTP骤减：衰老神经元的隐形“饥荒” 随着年龄的增长，神经元的“能量账本”开始出现亏空。人们最熟悉的，是ATP这张“大钞”逐渐减少，从而影响到电离子稳态、突触信号传递等一系列关键环节。然而，账本上还有另一张容易被忽视却同样重要的“支票”——GTP。它不仅是信号传导中的分子开关，还在维持蛋白质稳态方面发挥着核心作用，尤其在自噬和囊泡运输等生命活动中，更是不可或缺的能量与调控来源。结果发现，随着年龄增长，自由GTP与结合态GTP的比值随年龄增加而显著降低，这一变化直接指向神经元在老化过程中存在明显的GTP能量匮乏。考虑到GTP主要由线粒体TCA循环中琥珀酰辅酶A合成酶催化生成，研究还进一步进行了亚细胞定位。检测发现，线粒体内的游离GTP明显减少——也就是说，作为GTP“生产基地”的线粒体其代谢功能与GTP合成能力在衰老以及带有AD基因型的神经元中出现了下降。与此并行的是细胞质中开始出现大量富含GTP信号的囊泡状结构，这些异常积聚提示细胞在处理含GTP的囊泡或清除废物时可能受阻。从囊泡运输和降解的角度来看，两种关键的小GTP酶——Rab7和Arl8b，扮演着细胞内蛋白质清除的核心角色，尤其是在通过自噬途径处理错误折叠或聚集蛋白时不可或缺。研究进一步发现，Rab7和Arl8b在3xTg-AD神经元的轴突和树突中显著积累，这反映出内吞体与溶酶体之间的融合及降解功能受损，导致囊泡及病理蛋白异常堆积。 “能量补给+火力控制”双管齐下这场神经元的“能量危机”到底该如何破解？众所周知，随着年龄增长，神经元的“能量工厂”——线粒体渐渐力不从心，功能减弱，抗氧化能力也大幅下降，细胞内部的氧化还原平衡逐渐失调。过去的研究早已提示，老年神经元维持线粒体游离NADH的能力明显下降，导致能量供应告急，细胞“电力”不足。针对这一难题，研究团队想到了一招妙计：用烟酰胺，也就是大家熟悉的维生素B3，来补充NAD+的“原材料”，帮助细胞加速糖酵解和三羧酸循环这两个重要的“发电环节”，从而促进GTP的合成和线粒体代谢的恢复。不过，给线粒体“加油”的同时也可能无意中增加了氧自由基的“火力”，让细胞的氧化压力更大。为此，他们又引入了绿茶中的“明星”成分EGCG，这个天然的Nrf2通路激活剂，像启动了细胞内部的“防护盾”，有效激活抗氧化系统，帮细胞减轻氧化损伤。总的来说，这项研究表明，通过联合使用烟酰胺和Nrf2诱导剂EGCG，可以在短时间内恢复老年神经元的GTP水平，改善自噬功能，清除Aβ蛋白聚集体，并降低蛋白质氧化水平。 B族维生素，藏着脑力防护“密码” 其实，不管是维生素，还是绿茶，单独拎出来也是很能打的。来自上海市第六人民医院的研究团队发表于Nutrients的一项研究[3]就发现了维生素补充剂在预防认知能力下降方面的影响——每天补充维生素，包括叶酸、B族维生素、维生素D、辅酶Q10（CoQ10），能够有效延缓老年人认知衰退和神经退化的发生。为什么B族维生素会有这样的效果？研究者指出，B族是一个大家族，包含硫胺素、核黄素、烟酸、泛酸、维生素B6、叶酸、生物素和维生素B12等。有前瞻性分析发现，充足的叶酸、B6和B12摄入与“更好的认知储备”相关，可能原因是氧化还原相关基因（NUDT15和TXNRD1）的高甲基化以及氧化损伤的减少。话虽如此，单独一种B族维生素对不同人群的具体效果如何，还需要更细致的分项研究来给出答案。绿茶不仅护脑，还能降压说到这里，绿茶的魅力不仅仅体现在“护脑抗衰”这一方面。除了帮助神经元抵御岁月的侵蚀，绿茶还有一项广受欢迎的功效——调节血压。一项发表在Blood Pressure的研究[4]指出，绿茶能够显著降低成人的收缩压和舒张压，而且这种降压效果在血压本就偏高的人群中尤为明显。那么，B族维生素该怎么补充，绿茶喝多少量适宜呢？当脑中的“迷雾”初现端倪，或血压计上的数字开始不安分地跳跃——或许，书桌上那杯温润的绿茶，与几片不起眼的维生素B，就是此刻最温和的“内部调节器”。让细胞的能量工厂重新运作，让血管的“潮汐”归于平静，有时就藏在今日这份朴素的“补给”里。仍需指出的是，研究[2]使用体外单层神经元模型来模拟代谢功能障碍，可能无法完全反映体内环境中细胞外基质的复杂性，且缺乏来自老化免疫系统、血液供应和激素的影响；研究[3]采用横断面研究设计，因而无法确定因果关系；研究[4]纳入的研究存在显著的异质性，且缺乏关于剂量和干预持续时间对效果的明确影响，无法确定绿茶补充剂对血压的剂量-反应关系。参考资料： [1]Wang, G., Qi, J., Liu, X., et al. (2024). China Alzheimer Report 2024. Journal of Diagnostic Concepts and Practice, 23(3), 219-257. [2]Santana RA, McWhirt JM, Brewer GJ. Treatment of age-related decreases in GTP levels restores endocytosis and autophagy. Geroscience. 2025 Aug 2. doi: 10.1007/s11357-025-01786-4. Epub ahead of print. PMID: 40751793. [3]Jiang X, Guo Y, Cui L, Huang L, Guo Q, Huang G. Study of Diet Habits and Cognitive Function in the Chinese Middle-Aged and Elderly Population: The Association between Folic Acid, B Vitamins, Vitamin D, Coenzyme Q10 Supplementation and Cognitive Ability. Nutrients. 2023 Mar 1;15(5):1243. doi: 10.3390/nu15051243. PMID: 36904242; PMCID: PMC10005055. [4]Rezaei M, Akhavan N, Fathi F, Alavi SM, Fadaii M, Dehzad MJ, Askarpour M. Effect of green tea supplementation on blood pressure in adults: a GRADE-assessed systematic review and dose-response meta-analysis of randomised controlled trials. Blood Press. 2025 Dec;34(1):2517122. doi: 10.1080/08037051.2025.2517122. Epub 2025 Jun 12. PMID: 40497293. [5]中华人民共和国国家卫生健康委员会. 中国居民膳食营养素参考摄入量第5部分：水溶性维生素：WS/T 578.5—2018[S]. 北京：中国标准出版社，2018. [6]EFSA ANS Panel (2018). Scientific Opinion on the safety of green tea catechins. EFSA Journal, 16(4), 5239. https://doi.org/10.2903/j.efsa.2018.5239 撰文 | 木白编辑 | 木白来源 | 梅斯医学部分文字来源于网络，本文仅用于分享，转载请注明出处。若有侵权，请联系微信：bioonSir 删除或修改！精彩推荐： 1、偶尔的熬夜+赖床反而有利于大脑？！最新研究：睡眠规律性确与认知功能有关，但并不是越规律越好，适度的灵活性才是大脑最喜欢的节奏 2、你会选择「一百万」or「985学历」？Nature子刊科学分析：收入管“开心”，教育管“健康”，两者效应在中等以上水平后均趋缓 3、非必要不做CT，再添新证！CT辐射或引发超10万例新发癌症；高剂量辐射癌症风险达2.66倍；每多做一次CT，血液肿瘤风险升43% 4、睫毛长度竟会影响你的“性”号？！最新研究：睫毛长度与眼宽比率0.35是黄金比，过长的睫毛会使得吸引力和健康分下降，但性接受度上升 5、爱运动的人真能更长寿？双胞胎研究揭示真相：运动与衰老之间呈U型关系，只能短期内提升健康，而遗传和基础健康状况才是决定寿命的关键点击下方「阅读原文」，前往生物谷官网查询更多生物相关资讯~

2025-07-18

·CPHI制药在线

中药汤剂自组装及其应用

关注并星标CPHI制药在线中药自组装是指中药活性成分由于非共价键力，即氢键、静电力、范德华力、π-π 堆积等相互作用，自发排列成有序结构（如纳米颗粒、纳米纤维、胶束和囊泡）的过程。研究发现，中药从生药、炮制、煎煮、制剂的成型和储存以及最终给药到体内等多个阶段都存在自组装现象。中药材含有多种不同的活性成分，包括生物碱、黄酮类化合物、多糖、挥发油、苷类、鞣质等，这些成分具有不同的药理作用和药效。它们之间的自组装行为可以发生在同种成分中，也可发生在不同成分间。如多糖类结构中含有大量的亲水基团，其可以通过氢键或疏水基团与其他结构自组装成不同复合物，进而实现药理作用的改善。蛋白质分子间自组装以弱相互作用为主，通过氢键、范德华力、静电、疏水作用等多种作用力的加合而成。三萜类化合物在自然界中广泛存在，人参、甘草、紫苏、黄芪等多种中药中都含有多种三萜的苷元及苷。三萜类化合物具有独特的手性结构、多修饰位点、良好的生物相容性和可控的降解性。三萜类化合物自组装的形成主要是通过其刚性骨架间的范德华作用以及分子间的氢键实现的。中药自组装的研究应用1、作为天然纳米载体中药汤剂自组装不仅具有人工合成纳米材料一样的药物包封能力，还具有优于人工合成纳米材料的生物可降解性、生物相容性和安全性，可以作为天然纳米载体，用于药物递送，改善药物的生物利用度，增强药物疗效。目前，苦杏仁蛋白自组装纳米颗粒、太子参蛋白自组装纳米颗粒及生姜脂质自组装纳米颗粒等已被成功用于抗肿瘤药物紫杉醇、姜黄素及多柔比星等的递送。甘草有效成分甘草酸具有两亲性，能够聚集形成自组装胶束，作为多功能药物载体被广泛用于改善药物吸收。此外，生姜脂质自组装纳米颗粒可以结肠靶向递送 siRNA 用于结肠炎的治疗，同时可能具有协同抗炎疗效；甘草蛋白自组装纳米颗粒能够包载附子毒性成分乌头碱以降低其毒性反应。2、作为抗菌材料纳米抗菌是指利用纳米技术开发的一种抗菌技术，纳米级的材料具有较大的比表面积和独特的物理、化学性质，因此在抗菌方面具有独特的优势。无机纳米银是当前研究最广泛的无机抗菌材料，其具有抑菌能力强、耐高温、安全性好等优点，但也存在产率低、造价高、毒性不确定等缺点。天然纳米抗菌剂具有抗菌性好、无毒性、绿色安全等优势，逐渐进入了人们的视野。研究发现，从芍药甘草汤中分离出的自组装纳米颗粒可以降低多种炎症因子的表达水平，减少炎性细胞浸润等，从而达到治疗银屑病小鼠的目的。天然中药提取物小檗碱与肉桂酸可以通过氢键和π-π堆积自组装形成蝶形三维结构纳米颗粒，该纳米颗粒具有良好的抑菌活性，对耐多药金黄色葡萄球菌（methicillin-resistant Staphylococcus aureus，MRSA）有较好的抑制作用，并具有更强的生物膜去除能力，其生物相容性和连续释放特性良好，毒性也较小。3、降低毒性作用甘草具有解百毒的功效，常在组方中起解毒、调和诸药的作用。《本草纲目·草部第十二卷》引甄权语："诸药中甘草为君，治七十二种乳石毒，解一千二百般草木毒，调和众药有功，故有国老之号。"甘草常与雷公藤、马钱子、附子等配伍，起到减毒的作用。研究发现，甘草和附子在煎煮过程中蛋白质会发生自组装行，通过自组装，甘草蛋白与乌头碱可形成平均粒径为（238.20±1.23）nm 的甘草蛋白-乌头碱稳定胶体颗粒。通过小鼠急性毒性实验发现，注射乌头碱单体的小鼠全部死亡，而注射相同乌头碱含量的甘草蛋白-乌头碱颗粒的小鼠全部存活，且该胶体颗粒在室温下较稳定，具有成为药物候选载体的可能性。4、增溶作用中药汤剂中包含了许多种难溶性成分，部分中药纳米自组装颗粒通过自发性的亲疏水作用或表面修饰的相互作用实现纳米粒子组装。在这个过程中，其特殊的结构特性，可以改善疏水药物的水溶性。如三萜皂苷类成分具有表面活性剂的性质，可起到增溶的作用。研究发现，甘草中三萜皂苷类成分甘草酸同时存在亲水和疏水部分，有类似表面活性剂的结构特点，可以自组装形成凝胶纳米聚集体。随着甘草酸的浓度增加，薯蓣皂苷元和齐墩果酸在水溶液中的溶解度呈上升趋势，甘草酸溶液的浓度达到 1 mmol·L⁻¹时，薯蓣皂苷元及齐墩果酸的溶解度均增加约 60倍，薯蓣皂苷元的溶解度由 6.15 ng·mL⁻¹提升到了 360.59 ng·mL⁻¹，齐墩果酸的溶解度由 20.09 ng·mL⁻¹提升到了 1155.36 ng·mL⁻¹。5、在抗肿瘤方面的研究中药自组装纳米颗粒联合化疗药物进行抗肿瘤治疗不仅可以提高化疗药物的溶解度和稳定性，还能增强其靶向和释放能力，通过不同的抗肿瘤途径达到协同增效的目的。研究发现，从苦杏仁中分离出的11S 球蛋白进行热处理时存在自组装行为，结合键类型主要以二硫键、氢键为主。在碱性环境下，蛋白质浓度越高，自组装发生的速率越快；温度越高，形成的纳米颗粒的粒径越大，且形成的纳米颗粒具有良好的低温稳定性。通过用该纳米颗粒装载抗癌药物苦杏仁苷与紫杉醇，可以提升抗癌药物对癌细胞增殖的抑制作用，对人乳腺癌细胞（human breast cancer cells，MCF-7）增殖抑制率提高了42.88%。熊果酸（ursolic acid，UA）是一种三萜类化合物，具有抗肿瘤转移、抗血管生成、抗炎和抗增殖的潜力作用，是天然植物夏枯草或铁冬青的有效成分之一。表没食子儿茶素没食子酸酯（epigallocatechin gallate，EGCG）是绿茶中含量较丰富的成分之一，具有抗肿瘤、抗氧化和心血管保护能力。 UA 与EGCG 可以通过氢键和疏水作用自组装成纳米粒，通过上皮细胞黏附分子（epithelial cell adhesion molecule，EpCAM）适配体修饰的 UA 和EGCG 的无载体、自组装的纳米药物，用于靶向荷瘤小鼠肝细胞癌（hepatocellular carcinoma，HCC）治疗，发现该自组装纳米颗粒能明显抑制肿瘤生长，且对小鼠无明显的毒性。6、揭示中药配伍机制研究中药自组装的发现有助于以新的视角揭示中药复方配伍减毒增效的作用机制。中药自组装的形成既能够包载活性成分，产生增溶及促吸收作用，增强疗效；也可以包载毒性成分，延缓或抑制毒性成分的吸收，减弱毒副作用。研究发现，葛根芩连汤自组装的形成能够促进黄芩苷的吸收及抗氧化活性；麻杏石甘汤中形成的自组装能够包载其有效成分麻黄碱和伪麻黄碱，表现出不同的细胞（Caco-2、L-02、Hep G2、NR-8383、HeLa-229）增殖抑制活性；白虎汤中形成的自组装相比其他部位（溶液或沉淀）具有更好的解热作用，与全方的解热作用一致，且具有一定的肺脑靶向性。此外，中药小分子有效成分可以参与自组装的形成，有利于其自身的吸收和细胞摄取，表现出更强的生物活性。黄连有效成分小檗碱可以与黄芩有效成分黄芩苷自组装球形成纳米粒，该自组装具有显著优于小檗碱的抗菌活性，且显示出与黄连解毒汤类似的神经细胞保护作用，这在一定程度上揭示了黄连解毒汤的配伍增效机制。7、中药新药发现新策略中药自组装的发现不仅有助于揭示中药配伍理论的科学内涵，还为中药新药的开发提供了新策略。中药汤剂自组装的形成不仅影响有效成分的吸收，还可能具有优于有效成分或其简单混合物的生物活性。如果自组装的形成只是通过促进有效成分的吸收而增强药效，则可以将有效成分分离纯化，采用新型递药技术促进有效成分的吸收，增强药效；这样能够有效避免中药物质基础复杂、作用机制不清及质控困难等问题。若是中药汤剂自组装的形成表现出显著优于有效成分或其简单混合物的生物活性，则表明自组装可能是中药及复方药效发挥的物质基础真实形态，以自组装为基础开发新药，可能具有更好的成药性，这无疑为中药新药的开发提供了一种全新的研究策略。参考资料：[1]李斌,王慧敏,刘善钊.中药汤剂自组装技术的研究进展[J].西北药学杂志,2025,40(01):225-234.[2]沈成英,胡菲,朱君君,等.中药自组装纳米粒的形成及应用研究进展[J].中国中药杂志,2021,46(19):4875-4880.作者简介：小米虫，药品质量研究工作者，长期致力于药品质量研究及药品分析方法验证工作，现就职于国内某大型药物研发公司，从事药品检验分析及分析方法验证。END来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

siRNA

2025-06-25

·EINPresswire

Altin Biosciences announces US patent approval for its first-in-class, non-hormonal, oral botanical drug candidate.

A non-surgical, non-hormonal drug that is easy to take, easy to tolerate, and preserves fertility is exactly what patients and doctors have demanded for years. Altin's drug candidate is a significant advancement to offer fibroid patients non-hormonal treatment options that go beyond merely addressing symptoms, offering a paradigm shift in fibroid treatment.” — Ayman Al-Hendy, M.D., Ph.D.,FACOG, University of Chicago EMERYVILLE, CA, UNITED STATES, June 25, 2025 / EINPresswire.com / -- Non-hormonal oral botanical uterine fibroid drug candidate receives USPTO patent approval. Altin Biosciences, a woman-founded botanical drug development company, is pleased to announce the USPTO has granted a Notice of Allowance for a Composition of Matter patent for its lead drug candidate, a non-hormonal, oral treatment for uterine fibroids. US Patent Application No. 18/115,690, titled CRILA ® AND EGCG COMPOSITIONS FOR TREATMENT OF FIBROIDS, protects Altin’s lead drug candidate, ABC-105/ABC-205. Founder and CEO, Sue McKinney, states, “ Altin's fibroid candidate meets the stated ideal for patients and doctors : easy to take, easy to tolerate, preserves fertility, and no hormones. Beyond symptomatic management, we aim to reduce or eliminate the tumors themselves. Altin’s plant-based formula, being developed under the FDA Botanical Drug Guidance, positions Altin for licensing agreements and partnership development for this novel approach to fibroid treatment. We’re pursuing FDA fast track status to meet this urgent need.” Pre-clinical studies utilizing the combination of natural compounds Crinum latifolium L var. crilae Tram & Khanh (Crila ® ) and epigallocatechin gallate (EGCG) showed apoptosis (cell death) and synergistic anti-proliferative (suppression of cell growth) effects on human fibroid cells. Dr. Ayman Al-Hendy, M.D., Ph.D., Chair of Altin Biosciences’ Medical Advisory Board, and Vice Chair for Research, Department of Obstetrics and Gynecology at University of Chicago, states: “Altin's drug candidate is a significant advancement to offer fibroid patients non-hormonal treatment options that go beyond merely addressing symptoms, offering a paradigm shift in fibroid treatment. Our study shows these natural compounds may provide a safe and cost-effective alternative to current hormonal fibroid therapies ." “Naturally occurring plant-based chemicals, like the potential drug candidate from Altin Biosciences, Crila + EGCG, is a promising drug candidate for evaluation through clinical trials for its safety and efficacy in treating gynecological conditions like uterine fibroids. Fibroids cause significant negative impact on the quality of life of women suffering from them. An effective non-hormonal intervention that reduces the fibroid size and associated symptoms would potentially alter fibroid management for millions of women in a positive manner.” Bhuchitra Singh, MD, MPH. Altin’s Chief Medical Officer and Director of Clinical Research, Department of Gynecology and Obstetrics, Division of Reproductive Sciences and Women’s Health Research, Johns Hopkins University School of Medicine. Uterine fibroids impact up to 80% of women, disproportionately impacting women of color.[1] These non-cancerous tumors cause debilitating symptoms and increase the risk of infertility, preterm delivery, post-partum hemorrhage, and anemia. Each year in the US alone, 300,000 elective hysterectomies are due to fibroids.[2] The direct and indirect annual costs associated with fibroids in the United States are $42.2 billion.[3] About Altin Biosciences Altin Biosciences is an impact-focused company in botanical drug development for unmet medical needs. Established in 2022, Altin’s lead drug candidate is backed by over 30 years of research by top scientists collaborating internationally and meets patient and physician preference for non-invasive, non-hormonal treatments that preserve fertility and reduce reliance on hysterectomy. Altin seeks to revolutionize the treatment of uterine fibroids and additional conditions, including menopause, endometriosis and prostate conditions. For more information, please visit altinbiosciences.com or write to info@altinbiosciences.com REFERENCES 1. Stewart EA, Cookson CL, Gandolfo RA, Schulze-Rath R. Epidemiology of uterine fibroids: a systematic review. BJOG. 2017;124(10):1501-1512. doi:10.1111/1471-0528.14640 2. Stoelinga B, Huirne J, Heymans MW, Reekers JA, Ankum WM, Hehenkamp WJK. The estimated volume of the fibroid uterus: a comparison of ultrasound and bimanual examination versus volume at MRI or hysterectomy. Eur J Obstet Gynecol Reprod Biol. 2015;184:89-96. doi:10.1016/j.ejogrb.2014.11.011. 3. Hazimeh D, Coco A, Casubhoy I, Segars J, Singh B. The Annual Economic Burden of Uterine Fibroids in the United States (2010 Versus 2022): A Comparative Cost-Analysis. Reprod Sci. 2024 Dec;31(12):3743-3756. doi: 10.1007/s43032-024-01727-0. Epub 2024 Oct 25. PMID: 39455488. Sue McKinney Altin Biosciences Corporation +1 252-452-6245 suemckinney@AltinBiosciences.com Visit us on social media: LinkedIn Bluesky YouTube Dr. Ayman Al-Hendy and Altin Biosciences CEO Sue McKinney discuss the fertility-friendly potential for Altin's non-hormonal uterine fibroid drug candidate. 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.

快速通道

100 项与表没食子儿茶素没食子酸酯相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	表没食子儿茶素没食子酸酯	-	DB12116

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
放射性皮炎	临床3期	墨西哥	Universidad de Guanajuato	2025-09-01
杜氏肌营养不良症	临床3期	德国	Charité - Universitätsmedizin Berlin	2010-12-30
阿尔茨海默症	临床3期	德国	Charité - Universitätsmedizin Berlin	2009-10-01
脑萎缩	临床3期	德国	-	2009-05-01
慢性进行性多发性硬化	临床3期	德国	-	2009-05-01
肝细胞癌	临床2期	美国	The University of Texas Southwestern Medical Center	2024-09-01
肝硬化	临床2期	美国	The University of Texas Southwestern Medical Center	2024-09-01
亨廷顿舞蹈病	临床2期	德国	Charité - Universitätsmedizin Berlin	2011-09-01
复发-缓解型多发性硬化	临床2期	德国	Charité - Universitätsmedizin Berlin	2007-09-01
肺动脉高压	临床前	美国	University of California, Los Angeles	2025-05-16

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临床结果

适应症

分期

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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


NCT05758571 (Pubmed) 人工标引	临床1/2期	肺炎	54	epigallocatechin-3-gallate7umol/L	築壓構鹹構壓遞顧構鬱(蓋鹽構築網淵範選窪壓) = 網憲餘獵鬱積築積範窪繭齋夢鏇壓鬱鹹鏇範顧 (遞繭網簾範遞鏇鑰蓋廠 ) 更多	积极	2024-04-17
NCT02008721 (PROMESA, CTgov)	临床3期	多系统萎缩	92	EGCG as putative neuroprotective agent (EGCG as Putative Neuroprotective Agent)	鑰繭鏇繭衊廠鹽憲艱壓(選觸獵醖艱醖築網網構) = 醖製範鬱顧鏇餘襯網願醖醖鑰蓋鏇艱窪鹽醖鑰 (鹹憲鬱構衊醖窪艱繭簾, 1.01) 更多	-	2024-03-12
				Placebo (Placebo)	鑰繭鏇繭衊廠鹽憲艱壓(選觸獵醖艱醖築網網構) = 鏇繭鹹憲選蓋觸鬱範顧醖醖鑰蓋鏇艱窪鹽醖鑰 (鹹憲鬱構衊醖窪艱繭簾, 0.99) 更多
ChiCTR2100053703 (ASTRO2023)	临床2期	盆腔肿瘤辅助	37	EGCG 400mg	顧願網築淵繭製鬱鏇選(鏇獵獵鹽構獵醖顧襯淵) = 齋夢廠鹽觸構選遞願憲網憲製製構鹹製廠夢夢 (鹽衊構鑰鹽淵餘淵廠廠 ) 更多	积极	2023-10-01
NCT02580279 (phase II clinical study, ASTRO2023)	临床2期	乳腺癌	-	EGCG and radiotherapy	艱鑰觸觸淵蓋壓糧糧願(膚蓋選觸齋襯蓋蓋積製) = 鹹積鑰鹹繭鏇糧淵顧艱遞築積構製蓋獵鬱構觸 (顧鹽廠鹹夢鏇壓鬱艱觸 ) 更多	积极	2023-10-01
				Control group (radiotherapy only)	艱鑰觸觸淵蓋壓糧糧願(膚蓋選觸齋襯蓋蓋積製) = 構網築簾製鏇簾繭夢糧遞築積構製蓋獵鬱構觸 (顧鹽廠鹹夢鏇壓鬱艱觸 ) 更多
NCT02580279 (phase II clinical study, Pubmed \| Int J Radiat Oncol Biol Phys)	临床2期	乳腺癌	-	EGCG and radiotherapy	鹹窪範艱襯顧觸齋製積(遞廠鹹夢遞觸夢鬱構製) = 襯壓壓網觸選衊鑰廠製構鬱襯積鬱壓鹹觸網襯 (醖鬱醖獵範獵製構蓋壓 ) 更多	积极	2023-10-01
				Control group (radiotherapy only)	鹹窪範艱襯顧觸齋製積(遞廠鹹夢遞觸夢鬱構製) = 範願觸鏇鬱齋遞壓遞選構鬱襯積鬱壓鹹觸網襯 (醖鬱醖獵範獵製構蓋壓 ) 更多
NCT02580279 (Pubmed)	临床1期	肿瘤 \| 皮炎	19	EGCG solution	膚願鏇齋繭齋糧鑰廠網(廠壓窪糧淵廠繭遞簾蓋) = significant relief can be observed in burning sensation after 15 days of EGCG treatment 淵願選鏇鬱淵壓醖選觸 (獵壓餘憲鬱夢觸夢製顧 ) 更多	-	2023-08-24
NCT03928847 (CTgov)	早期临床1期	特发性肺纤维化	35	Epigallocatechin-3-gallate (EGCG) (EGCG PK in Healthy Volunteers 450 mg)	簾壓簾構積夢鹽積夢醖(蓋餘廠鑰醖製選衊範醖) = 網窪齋蓋膚餘網願選齋選憲構蓋淵願鑰廠醖壓 (鑰獵餘製廠選鹹顧壓簾, NA) 更多	-	2022-12-22
				Epigallocatechin-3-gallate (EGCG) (EGCG PK in Healthy Volunteers 750 mg)	簾壓簾構積夢鹽積夢醖(蓋餘廠鑰醖製選衊範醖) = 糧艱顧積繭範廠醖鹹範選憲構蓋淵願鑰廠醖壓 (鑰獵餘製廠選鹹顧壓簾, NA) 更多
ChiCTR2000029831 (Pubmed \| BMC Oral Health)	早期临床1期	慢性牙周炎	20	SRP plus EGCG medication	鹽獵築衊餘構壓餘繭鏇(餘膚淵鑰淵鹽網選鏇夢) = 築鹽範窪夢壓構遞齋鑰夢衊構顧壓襯遞糧築艱 (窪壓遞獵築觸廠願窪餘 ) 更多	-	2021-02-18
NCT00799890 (SUPREMES, Pubmed \| Front Neurol)	临床2/3期	慢性进行性多发性硬化	31	EGCG treated	鬱製膚憲遞觸積糧鏇觸(鬱鏇遞構餘製築襯鑰膚) = 選繭遞壓構夢襯繭願鹽鹽衊顧餘憲壓獵壓窪蓋 (淵積憲憲齋襯鑰醖艱壓, [0.67]) 更多	-	2021-01-01
				Placebo	鬱製膚憲遞觸積糧鏇觸(鬱鏇遞構餘製築襯鑰膚) = 觸餘醖淵夢範蓋構範廠鹽衊顧餘憲壓獵壓窪蓋 (淵積憲憲齋襯鑰醖艱壓, [0.47]) 更多
NCT01928485 (CTgov)	临床2期	前列腺癌	6	active surveillance (Arm A (Active Surveillance))	襯窪鏇簾窪築顧網觸艱(鹹齋衊簾窪製衊廠積淵) = 鬱顧齋製襯遞夢鬱蓋積夢憲夢簾顧壓糧膚鏇選 (網齋廠觸鬱積製淵窪網, 2.29) 更多	-	2020-03-03
				laboratory biomarker analysis+Sunphenon (Arm B (Sunphenon))	襯窪鏇簾窪築顧網觸艱(鹹齋衊簾窪製衊廠積淵) = 顧壓窪顧襯襯壓鏇淵夢夢憲夢簾顧壓糧膚鏇選 (網齋廠觸鬱積製淵窪網, NA) 更多