FDA已批准鼻用制剂的辅料分析及研究进展  

Research Advances and Analysis of Excipients Used in Nasal Drugs New Approved by FDA

作　　者：方笑语 葛渊源 FANG Xiaoyu;GE Yuanyuan(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201210,China)

机构地区：[1]上海药品审评核查中心,上海201210

出　　处：《中国现代应用药学》2023年第20期2811-2817,共7页Chinese Journal of Modern Applied Pharmacy

摘　　要：因鼻腔构造的特殊性,在鼻用制剂处方中加入功能性辅料,可起到改善药物活性物质的透膜吸收或减少鼻黏膜纤毛的清除作用,对维持药物活性物质在目标区域的有效浓度,促进鼻黏膜吸收起着重要作用。本文通过对美国食品药品监督管理局近十年已批准上市的鼻腔制剂新药中使用的辅料进行汇总分析,并结合鼻用辅料目前研究进展与安全性评价情况对其进行综述,为开发鼻用制剂在辅料选择上提供思路和借鉴。Due to the special structure of the nasal cavity,the addition of functional excipients in nasal drugs can improve the transmembrane absorption of the active pharmaceutical ingredient or reduce the clearance of nasal mucocilia,which plays an important role in maintaining the effective concentration of active pharmaceutical ingredient in the target area and promoting the absorption of nasal mucosa.In this paper,the excipients used in drug new approved by the United States Food and Drug Administration(FDA)in the past decade were summarized,and the current research advances and safety evaluation of excipients for nasal drug were reviewed,providing ideas and references for the selection of excipients for nasal drug development.

关 键 词：美国食品药品监督管理局 鼻用制剂 辅料 安全性评价 

分 类 号：R943[医药卫生—药剂学]