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精确的纳米级制造技术,药物研发的“最后一公里”。

Precise nanoscale fabrication technologies, the "last mile" of medicinal development.

作者信息

Bi Ye, Xie Sensen, Li Ziwei, Dong Shiyan, Teng Lesheng

机构信息

Practice Training Center, Changchun University of Chinese Medicine, Changchun 130117, China.

Public Experimental Center, Changchun University of Chinese Medicine, Changchun 130117, China.

出版信息

Acta Pharm Sin B. 2025 May;15(5):2372-2401. doi: 10.1016/j.apsb.2025.03.040. Epub 2025 Mar 18.

Abstract

Nanotechnologies seek to overcome inherent deficiencies of conventional diagnosis and treatment, which attracted sustained attention and a limited number of nanomedicines approved by the FDA. However, the critical gaps in clinical translation remain, and nanomedicines that were initially heralded as magic bullets have yet to reach their realistic potential. The major obstacles of fabrication technologies may be overlooked in the nanoparticles' journey. Suboptimal manufacturing strategies partly hampered the inefficient transformation. In this review, we discuss the nanoparticle manufacturing strategies of "Top-Down" and "Bottom-Up" on precise nanoscale fabrication, including artificial intelligence introduced to guided nanomedicine fabrication for accelerating the transformation. Re-engineering existing nanomedicine fabrication, individual manufacturing, and modular technology might highlight the dilemmas of nanomedicines to meet their initial expectations.

摘要

纳米技术旨在克服传统诊断和治疗的固有缺陷,这引起了持续关注,并且有少数纳米药物获得了美国食品药品监督管理局(FDA)的批准。然而,临床转化中的关键差距仍然存在,最初被誉为神奇子弹的纳米药物尚未发挥其实际潜力。在纳米颗粒的发展过程中,制造技术的主要障碍可能被忽视了。次优的制造策略在一定程度上阻碍了低效的转化。在本综述中,我们讨论了“自上而下”和“自下而上”的纳米颗粒制造策略在精确纳米级制造方面的应用,包括引入人工智能以指导纳米药物制造以加速转化。重新设计现有的纳米药物制造、个体化制造和模块化技术可能会凸显纳米药物面临的困境,以满足其最初的期望。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7263/12145073/5d527043bcc2/ga1.jpg

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