美国FDA批准鼻脑给药相关的鼻喷雾剂说明书分析

Label Analysis of FDA Approved Nasal-brain Delivery Related Preparations

关键词:  鼻喷雾剂  鼻脑给药  药品说明书

Key words:  nasal spray  nasal-brain administration  label

摘要:

鼻用制剂是指将药物直接用于鼻腔，发挥局部或全身作用的制剂。鼻用制剂具有吸收起效迅速，生物利用度高，能避免肝脏首过效应，患者依从性较高等临床优势。鼻用制剂可经嗅神经或三叉神经分支绕过血脑屏障实现直接对中枢神经系统给药，为脑部或中枢神经系统疾病的治疗提供了一种相对更安全、有效和便捷的给药途径。本文收集了美国食品药品监督管理局（Food and Drug Administration，FDA）批准上市鼻喷雾剂产品中鼻脑给药相关产品的说明书信息，并对比分析了不同品种说明书信息间的共性和差异，为未来国内鼻用制剂的开发提供参考。

Abstract:

Nasal preparation are preparations that directly delivery drugs on the nasal cavity and exert local or systemic effects. It has the clinical advantages of rapid absorption, high bioavailability, avoid the first-pass effect of liver, and better patient compliance, et al. For nasal-brain administration, nasal preparation can be administered directly to the central nervous system(CNS) via olfactory nerve or trigeminal nerve bypassing the blood-brain barrier, which providing a sager, more effective and convenient route for brain or CNS diseases. In this paper, the label information of Food and Drug Administration(FDA) approved nasal-brain delivery related nasal spray preparations was reviewed, the similarities and differences between these nasal preparations were analyzed in order to provide reference for the development of domestic nasal preparations.