生物表面活性剂在药物应用中的监管现状和前景。

Regulatory status quo and prospects for biosurfactants in pharmaceutical applications.

机构信息

Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Eötvös Str. 6, H-6720 Szeged, Hungary; Department of Applied and Environmental Chemistry, Institute of Chemistry, Faculty of Science and Informatics, University of Szeged, Rerrich Bela Sq.1., H-6720 Szeged, Hungary.

Department of Medical Microbiology and Immunobiology, Faculty of Medicine, University of Szeged, 10 Dóm Square, H-6720 Szeged, Hungary.

出版信息

Drug Discov Today. 2021 Aug;26(8):1929-1935. doi: 10.1016/j.drudis.2021.03.029. Epub 2021 Apr 5.

DOI:10.1016/j.drudis.2021.03.029

PMID:33831583

Abstract

The concept of going 'green' and 'cold' has led to utilizing renewable resources for the synthesis of microbial biosurfactants that are both patient and eco-friendly. In this review, we shed light on the potential and regulatory aspects of biosurfactants in pharmaceutical applications and how they can significantly contribute to novel concepts for the Coronavirus 2019 (COVID-19) vaccine and future treatment. We emphasize that more specific guidelines should be formulated to regulate the approval of biosurfactants for human use. It is also crucial to implement a risk-based approach from the early research and development (R&D) phase in addition to establishing more robust standardized techniques and assays to evaluate the characteristics of biosurfactants.

摘要

“绿色”和“冷”的概念促使人们利用可再生资源来合成对患者和环境友好的微生物生物表面活性剂。在这篇综述中，我们探讨了生物表面活性剂在药物应用中的潜力和监管方面，以及它们如何为 2019 年冠状病毒（COVID-19）疫苗和未来的治疗方法提供新的概念。我们强调，应制定更具体的准则来规范生物表面活性剂用于人体的批准。此外，除了建立更强大的标准化技术和测定法来评估生物表面活性剂的特性外，从早期的研究和开发（R&D）阶段开始就采用基于风险的方法也至关重要。