• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利:CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验

纳米医学:原理、特性及监管问题

Nanomedicine: Principles, Properties, and Regulatory Issues.

作者信息

Soares Sara, Sousa João, Pais Alberto, Vitorino Carla

机构信息

Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.

REQUIMTE/LAQV, Group of Pharmaceutical Technology, Faculty of Pharmacy, University of Coimbra, Coimbra, Portugal.

出版信息

Front Chem. 2018 Aug 20;6:360. doi: 10.3389/fchem.2018.00360. eCollection 2018.

DOI:10.3389/fchem.2018.00360
PMID:30177965
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6109690/
Abstract

Several scientific areas have benefited significantly from the introduction of nanotechnology and the respective evolution. This is especially noteworthy in the development of new drug substances and products. This review focuses on the introduction of nanomedicines in the pharmaceutical market, and all the controversy associated to basic concepts related to these nanosystems, and the numerous methodologies applied for enhanced knowledge. Due to the properties conferred by the nanoscale, the challenges for nanotechnology implementation, specifically in the pharmaceutical development of new drug products and respective regulatory issues are critically discussed, mainly focused on the European Union context. Finally, issues pertaining to the current applications and future developments are presented.

摘要

纳米技术的引入及其相应的发展使多个科学领域受益匪浅。这在新药物和产品的开发中尤为显著。本综述聚焦于纳米药物在医药市场的引入、与这些纳米系统基本概念相关的所有争议,以及为增进认识而应用的众多方法。由于纳米尺度赋予的特性,本文批判性地讨论了纳米技术实施面临的挑战,特别是在新药品的药物研发及相关监管问题方面,主要聚焦于欧盟背景。最后,介绍了当前应用和未来发展相关的问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c846/6109690/ff801e1daeb6/fchem-06-00360-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c846/6109690/8837de312cae/fchem-06-00360-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c846/6109690/c7c078b91bcb/fchem-06-00360-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c846/6109690/ff801e1daeb6/fchem-06-00360-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c846/6109690/8837de312cae/fchem-06-00360-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c846/6109690/c7c078b91bcb/fchem-06-00360-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c846/6109690/ff801e1daeb6/fchem-06-00360-g0003.jpg

相似文献

1
Nanomedicine: Principles, Properties, and Regulatory Issues.纳米医学:原理、特性及监管问题
Front Chem. 2018 Aug 20;6:360. doi: 10.3389/fchem.2018.00360. eCollection 2018.
2
Personalized Nanomedicine: A Revolution at the Nanoscale.个性化纳米医学:纳米尺度的一场革命。
J Pers Med. 2017 Oct 12;7(4):12. doi: 10.3390/jpm7040012.
3
Where Is Nano Today and Where Is It Headed? A Review of Nanomedicine and the Dilemma of Nanotoxicology.纳米技术的现状与未来走向:纳米医学综述及纳米毒理学困境
ACS Nano. 2022 Jul 26;16(7):9994-10041. doi: 10.1021/acsnano.2c00128. Epub 2022 Jun 21.
4
Feeding Next-Generation Nanomedicines to Europe: Regulatory and Quality Challenges.向欧洲输送下一代纳米药物:监管和质量挑战。
Adv Healthc Mater. 2023 Dec;12(30):e2301956. doi: 10.1002/adhm.202301956. Epub 2023 Sep 17.
5
Nanomedicines accessible in the market for clinical interventions.可用于临床干预的市售纳米药物。
J Control Release. 2021 Feb 10;330:372-397. doi: 10.1016/j.jconrel.2020.12.034. Epub 2020 Dec 25.
6
Development of Pharmaceutical Nanomedicines: From the Bench to the Market.药物纳米医学的发展:从实验室到市场
Pharmaceutics. 2022 Jan 3;14(1):106. doi: 10.3390/pharmaceutics14010106.
7
Engineered Nanomaterials: The Challenges and Opportunities for Nanomedicines.工程纳米材料:纳米药物的挑战与机遇。
Int J Nanomedicine. 2021 Jan 8;16:161-184. doi: 10.2147/IJN.S288236. eCollection 2021.
8
Issues affecting nanomedicines on the way from the bench to the market.影响纳米药物从实验室走向市场的问题。
J Mater Chem B. 2020 Dec 21;8(47):10681-10685. doi: 10.1039/d0tb02180f. Epub 2020 Nov 6.
9
Nanomedicines for Renal Management: From Imaging to Treatment.纳米医学在肾脏管理中的应用:从成像到治疗。
Acc Chem Res. 2020 Sep 15;53(9):1869-1880. doi: 10.1021/acs.accounts.0c00323. Epub 2020 Aug 12.
10
A review of the current scientific and regulatory status of nanomedicines and the challenges ahead.纳米药物的当前科学与监管现状及未来挑战综述。
PDA J Pharm Sci Technol. 2011 Mar-Apr;65(2):177-95.

引用本文的文献

1
Delivery strategies to improve the pharmacological efficacy of NRF2 modulators: a review.提高NRF2调节剂药理疗效的给药策略:综述
RSC Med Chem. 2025 Aug 22. doi: 10.1039/d5md00571j.
2
Antimicrobial Nanoparticles Against Superbugs: Mechanistic Insights, Biomedical Applications, and Translational Frontiers.抗超级细菌的抗菌纳米颗粒:作用机制洞察、生物医学应用及转化前沿
Pharmaceuticals (Basel). 2025 Aug 13;18(8):1195. doi: 10.3390/ph18081195.
3
Solid Lipid Nanoparticles and Nanostructured Lipid Carriers for Anticancer Phytochemical Delivery: Advances, Challenges, and Future Prospects.

本文引用的文献

1
Nanomedicines: current status and future perspectives in aspect of drug delivery and pharmacokinetics.纳米药物:药物递送与药代动力学方面的现状与未来展望
J Pharm Investig. 2018;48(1):43-60. doi: 10.1007/s40005-017-0370-4. Epub 2017 Nov 28.
2
Regulatory challenges of nanomedicines and their follow-on versions: A generic or similar approach?纳米药物及其后续版本的监管挑战:通用或类似方法?
Adv Drug Deliv Rev. 2018 Jun;131:122-131. doi: 10.1016/j.addr.2018.06.024. Epub 2018 Jun 30.
3
Relevance of Physicochemical Characterization of Nanomaterials for Understanding Nano-cellular Interactions.
用于抗癌植物化学物质递送的固体脂质纳米粒和纳米结构脂质载体:进展、挑战与未来展望
Pharmaceutics. 2025 Aug 21;17(8):1079. doi: 10.3390/pharmaceutics17081079.
4
Revolutionizing healthcare: the transformative potential of nanotechnology in medicine.变革医疗保健:纳米技术在医学中的变革潜力。
Front Drug Deliv. 2025 May 30;5:1556426. doi: 10.3389/fddev.2025.1556426. eCollection 2025.
5
Alkali Lignin-Based Biopolymer Formulations for Electro-Assisted Drug Delivery of Natural Antioxidants in Breast Cancer Cells-A Preliminary Study.基于碱木质素的生物聚合物制剂用于电辅助天然抗氧化剂在乳腺癌细胞中的药物递送——一项初步研究
Int J Mol Sci. 2025 Aug 2;26(15):7481. doi: 10.3390/ijms26157481.
6
Predicting the protein corona on nanoparticles using random forest models with nanoparticle, protein, and experimental features.使用具有纳米颗粒、蛋白质和实验特征的随机森林模型预测纳米颗粒上的蛋白质冠层。
Nanoscale Adv. 2025 Jul 29. doi: 10.1039/d5na00425j.
7
Safety Profile of Intravenous Ferulic Acid Nanoparticles: Acute Toxicity and Neurological Effects in Sprague-Dawley Rats.静脉注射阿魏酸纳米颗粒的安全性概况:对斯普拉格-道利大鼠的急性毒性和神经学影响
Nanotechnol Sci Appl. 2025 Jul 28;18:319-358. doi: 10.2147/NSA.S500407. eCollection 2025.
8
Optimizing carbon nanoparticle staining for sentinel lymph nodes in rabbit lower limb models: concentration and time dependence.优化兔下肢模型中前哨淋巴结的碳纳米颗粒染色:浓度和时间依赖性
PeerJ. 2025 Jul 31;13:e19799. doi: 10.7717/peerj.19799. eCollection 2025.
9
Engineering Nanoparticles and Bioscaffolds for Targeted microRNA Delivery in Cardiovascular Regeneration-A Comprehensive Review.用于心血管再生中靶向递送微小RNA的工程纳米颗粒和生物支架——综述
FASEB J. 2025 Jul 31;39(14):e70871. doi: 10.1096/fj.202501226RR.
10
Evaluating Biocompatibility: From Classical Techniques to State-of-the-Art Functional Proteomics.评估生物相容性:从经典技术到最先进的功能蛋白质组学
Nanomaterials (Basel). 2025 Jul 3;15(13):1032. doi: 10.3390/nano15131032.
纳米材料理化特性与纳米细胞相互作用关系研究
Adv Exp Med Biol. 2018;1048:123-142. doi: 10.1007/978-3-319-72041-8_8.
4
Decision tree models to classify nanomaterials according to the DF4nanoGrouping scheme.决策树模型,用于根据 DF4nanoGrouping 方案对纳米材料进行分类。
Nanotoxicology. 2018 Feb;12(1):1-17. doi: 10.1080/17435390.2017.1415388. Epub 2017 Dec 18.
5
How to select a nanosimilar.如何选择纳米相似物。
Ann N Y Acad Sci. 2017 Nov;1407(1):50-62. doi: 10.1111/nyas.13382. Epub 2017 Jul 17.
6
Quality-by-design of nanopharmaceuticals - a state of the art.纳米药物的质量设计——最新技术。
Nanomedicine. 2017 Oct;13(7):2151-2157. doi: 10.1016/j.nano.2017.05.014. Epub 2017 Jun 1.
7
Safety assessment of nanomaterials using an advanced decision-making framework, the DF4nanoGrouping.使用先进的决策框架DF4nanoGrouping对纳米材料进行安全性评估。
J Nanopart Res. 2017;19(5):171. doi: 10.1007/s11051-017-3850-6. Epub 2017 May 9.
8
Equivalence of complex drug products: advances in and challenges for current regulatory frameworks.复杂药品的等效性:当前监管框架的进展与挑战
Ann N Y Acad Sci. 2017 Nov;1407(1):39-49. doi: 10.1111/nyas.13347. Epub 2017 Apr 26.
9
Challenges associated and approaches for successful translation of nanomedicines into commercial products.纳米药物成功转化为商业产品所面临的挑战及方法。
Nanomedicine (Lond). 2017 Apr;12(8):819-823. doi: 10.2217/nnm-2017-0039. Epub 2017 Mar 24.
10
Nano on reflection.关于反射的纳米技术。
Nat Nanotechnol. 2016 Oct 5;11(10):828-834. doi: 10.1038/nnano.2016.232.