| 引用本文: | 马琳莎,贾国舒,周一萌,曹萌,刘芬.鼻用生物制品的进展与挑战[J].中国现代应用药学,2023,40(20):2802-2810. |
| MA Linsha,JIA Guoshu,ZHOU Yimeng,CAO Meng,LIU Fen.Advances and Challenges in Intranasal Biologics[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(20):2802-2810. |
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| 鼻用生物制品的进展与挑战 |
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马琳莎1,2, 贾国舒3, 周一萌4, 曹萌4, 刘芬4
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1.中国科学院大学, 北京 100049;2.上海科技大学, 上海 201210;3.中国药科大学, 南京 211198;4.上海药品审评核查中心, 上海 201210
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| 摘要: |
| 生物制品发展迅猛，在应对多类疾病的治疗时展现出其独特的优势与潜力。然而目前常用的口服、注射等给药方式中，生物制品常存在稳定性差、体内半衰期短、中枢神经系统利用度差等问题，限制了生物制品的应用范围与发展。通过鼻腔对生物制剂进行给药的鼻用生物制品，充分利用鼻腔中天然存在的鼻脑通路、黏膜免疫淋巴组织等功能组分递送药物分子，具有高效递送、提高药物利用度的潜力，成为一种很有前景的策略。本文通过已发表文献、临床试验数据库、相关产品信息等公开资料，从作用机制、应用现状、发展前景等方面对鼻用大分子治疗药物、鼻用疫苗及鼻用细胞疗法等鼻用生物制品主要类别的研究现状进行总结，进一步对鼻用生物制品的发展提出建议。 |
| 关键词: 鼻用生物制品 大分子药物 疫苗 细胞治疗 |
| DOI：10.13748/j.cnki.issn1007-7693.20231878 |
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| Advances and Challenges in Intranasal Biologics |
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MA Linsha1,2, JIA Guoshu3, ZHOU Yimeng4, CAO Meng4, LIU Fen4
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1.University of Chinese Academy of Sciences, Beijing 100049, China;2.ShanghaiTech University, Shanghai 201210, China;3.China Pharmaceutical University, Nanjing 211198, China;4.Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China
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| Abstract: |
| Biologics are developing rapidly and have demonstrated their unique advantages in the treatment of many diseases. And with common administration, like oral and injection, biological products often have problems in instability, short half-life and poor utilization of the central nervous system, which limits the application scope and development of biological products. Intranasal biologics are promising strategy taking advantages in nasal administration that bypass the restrictions in vivo, like blood-brain-barrier, to improve the drug avalibility in the target site, which have potential to improve efficient delivery and the availability. According to published literature, clinical databases, industry guidelines around the world, this review highlighted the rescent progress in intranasal macromolecular drugs, intranasal vaccine and intranasal cell therapy, which were the main fields of intranasal biologics, offering perspectives suggestions for the further development of this field. |
| Key words: intranasal biopharmaceutical macromolecular drugs vaccine cell therapy |
