鼻喷雾剂仿制制剂药学研究关注点探讨

Discussion on Pharmaceutical Research Concerns of Generic Nasal Spray Preparations

摘要: 近年来，鼻用制剂的研发日益成为热点，笔者通过调研文献，并结合相关指导原则，从鼻用喷雾剂处方工艺、给药装置、质量控制、生物等效性评价等方面，提出一些药学研究的关注点及一般考虑，质量控制重点关注雾滴分布、喷雾模式和喷雾形态，以期为此类产品的开发和评价提供参考。

Abstract: In recent years, the research and development of nasal preparations have increasingly become a hot topic. Through reviewing literature and combining relevant guiding principles, the author proposes some key points and general considerations for pharmaceutical research in the aspects of nasal spray formulation process, drug delivery device, quality control, and bioequivalence evaluation. The focus of quality control is on droplet size distribution, spray pattern, and plume geometry, with the aim of providing reference for the development and evaluation of nasal products.