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文中比较分析了目前国内外鼻喷剂的质量控制内容、方法及原理,详细阐述了国外用于表征喷雾雾滴大小及分布的方法及原理,如高速影像雾粒分析、激光衍射雾粒动态分析、显微图像识别结合拉曼光谱分析,并分析了这3种方法各自的特点及适用性。通过喷雾给药后雾滴在呼吸道内沉降分布的研究,结合鼻喷给药装置的研究进展,指出了目前鼻腔喷雾给药研究的热点和难点。简要分析了中国鼻喷剂研究与国外研究间的差距,并对鼻喷给药的应用开发前景进行了展望。
The contents, methods and principles of quality control of nasal sprays at home and abroad are comparatively analyzed. The methods and principles used to characterize the size and distribution of spray droplets in foreign countries are expounded in detail. For example, high-speed image fog analysis, laser diffraction fog analysis , Microscopic image recognition combined with Raman spectroscopy, and analyzed the respective characteristics and applicability of these three methods. Through the research on the distribution of the droplet in the respiratory tract after the spray administration, the research progress of the nasal spray administration device is pointed out, and the hot spots and difficulties in nasal spray administration are pointed out. This paper briefly analyzes the gap between nasal spray research in China and foreign studies and forecasts the prospect of application of nasal spray.