| 引用本文: | 黄奡,冉丽,王友如,熊长云.mRNA药物稳定性研究进展[J].中国现代应用药学,2024,41(18):39-50. |
| Huang Ao,Hubei Normal University,Wang Youru,Xiong Changyun.Research Progress on the Stability of mRNA Drugs[J].Chin J Mod Appl Pharm(中国现代应用药学),2024,41(18):39-50. |
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| 摘要: |
| mRNA药物在疾病预防和治疗方面具有潜力，但稳定性问题仍是其广泛应用的主要障碍。从mRNA药物的底层化学结构原理出发，详细介绍了mRNA的化学结构、5'帽子、非翻译区、ORF和poly（A）尾巴对稳定性的影响，并提出通过优化序列设计和采用修饰核苷来提高mRNA的稳定性。讨论了目前mRNA药物主流的LNP递送系统的组成及其在生产、储存和运输中的稳定性问题，并提出了优化LNP设计和生产工艺以提高稳定性的措施；提出了mRNA药物稳定性的评估方法，介绍了mRNA药物的质控方法和法规。 |
| 关键词: mRNA 修饰核苷 药物稳定性 脂质体纳米颗粒 |
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| Research Progress on the Stability of mRNA Drugs |
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Huang Ao, Hubei Normal University, Wang Youru, Xiong Changyun
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Ningbo Vigor Biotechnologics Co., Ltd.
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| Abstract: |
| mRNA drugs have the potential in disease prevention and treatment, but stability issues remain the main barrier to their widespread application. Based on the underlying chemical structure principles of mRNA drugs, this article provided a detailed introduction to the impact of the chemical structure of mRNA, 5' cap, untranslated region, open reading frame (ORF), and poly(A) tail on stability, and suggested improving mRNA stability through optimized sequence design and the use of modified nucleosides. It was discussed that the composition of the mainstream lipid nanoparticle (LNP) delivery system for mRNA drugs, and its stability issues in production, storage, and transportation, and proposes measures to optimize LNP design and manufacturing processes to enhance stability. It was presented that methods for assessing the stability of mRNA drugs, quality control methods for mRNA drugs and regulations were also disscussed. |
| Key words: mRNA modified nucleotide stability LNP |
