| 引用本文: | 方笑语,葛渊源.FDA已批准鼻用制剂的辅料分析及研究进展[J].中国现代应用药学,2023,40(20):2811-2817. |
| FANG Xiaoyu,GE Yuanyuan.Research Advances and Analysis of Excipients Used in Nasal Drugs New Approved by FDA[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(20):2811-2817. |
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| 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。 |
| 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 |
| DOI：10.13748/j.cnki.issn1007-7693.20232012 |
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| Research Advances and Analysis of Excipients Used in Nasal Drugs New Approved by FDA |
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FANG Xiaoyu, GE Yuanyuan
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Shanghai Center for Drug Evaluation and Inspection, Shanghai 201210, China
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| Abstract: |
| 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. |
| Key words: FDA nasal drug excipients safety evaluation |
