经鼻给药的机遇与挑战

廖萍; 曹萌; 张景辰; 陈桂良<sup>*</sup>

引用本文:	廖萍,曹萌,张景辰,陈桂良.经鼻给药的机遇与挑战[J].中国现代应用药学,2023,40(20):2761-2765.
	LIAO Ping,CAO Meng,ZHANG Jingchen,CHEN Guiliang.Opportunities and Challenges of Nasal Drug Delivery[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(20):2761-2765.

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经鼻给药的机遇与挑战
廖萍¹, 曹萌¹, 张景辰², 陈桂良¹
1.上海药品审评核查中心, 上海 201210;2.国家药品监督管理局药品审评检查长三角分中心, 上海 201210

摘要:

作为一种非侵入给药方式，鼻腔给药具有快速起效、使用方便、依从性高、无首过效应、不良反应较小、黏膜免疫等诸多优点，且提供了鼻脑递送途径，鼻用制剂日益成为研发热点，以着力解决未被满足的临床需求。但是，因鼻腔结构和生理学上的特殊性，鼻用制剂的开发和评价还存在诸多挑战。

关键词: 鼻用制剂鼻腔给药鼻脑递送监管科学

DOI：10.13748/j.cnki.issn1007-7693.20232901

分类号:R943

基金项目:

Opportunities and Challenges of Nasal Drug Delivery

LIAO Ping¹, CAO Meng¹, ZHANG Jingchen², CHEN Guiliang¹

1.Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China;2.Yangtze River Center for Drug Evaluation and Inspection of National Medical Products Administration, Shanghai 201210, China

Abstract:

As a non-invasive drug delivery method, nasal drug delivery has many advantages, such as rapid onset, easy use, high compliance, no first pass effect, fewer adverse reactions, mucosal immunity, and provides a new convenient route to deliver drugs to the brain through nose-to-brain delivery. Nasal formulations are increasingly becoming a research and development hotspot, focusing on addressing unmet clinical needs. However, due to the special structure and physiology of the nasal cavity, there are still many challenges in the development and evaluation of nasal preparations.

Key words: nasal preparation nasal drug delivery nose-to-brain delivery regulatory science