撞击器法评估吸入制剂空气动力学粒径分布的研究进展

空气动力学粒径分布（APSD）是吸入制剂体外质量评价的重要检测项目，级联撞击器法是国际公认的气溶胶APSD测定方法，并且已被多国药典收载。其通过体外模拟气溶胶经过呼吸道到达肺部不同部位的沉积情况，对吸入制剂的研究开发具有重要的指导意义。综述了目前国内外药典收载的双级液体撞击器、多级液体撞击器、马普尔-米勒撞击器、安德森级联撞击器、新一代撞击器等撞击器的主要结构以及应用情况。

An overview of aerodynamic particle size distribution of inhaled formulations by impactor methods

Aerodynamic particle size distribution (APSD) is an important item for in vitro quality assessment of inhalation products. The cascade impactor method is an internationally recognized method for the determination of APSD of aerosols, and it has been recorded in Multinational Pharmacopoeia. The method has important guiding significance for the research and development of generic drugs and innovative drugs for inhaled products by simulating the deposition of aerosols through the respiratory tract to different parts of the lungs in vitro. In this paper, the main structures and applications of the two-stage liquid impactors, multi-stage liquid impactors, Marple Miller impactors, Anderson cascade impactors and the new generation impactors contained in the current domestic and international pharmacopoeia are reviewed.