空氣動力學(xué)粒徑分布（APSD）是吸入制劑體外質(zhì)量評價(jià)的重要檢測項(xiàng)目，級聯(lián)撞擊器法是國際公認(rèn)的氣溶膠APSD測定方法，并且已被多國藥典收載。其通過體外模擬氣溶膠經(jīng)過呼吸道到達(dá)肺部不同部位的沉積情況，對吸入制劑的研究開發(fā)具有重要的指導(dǎo)意義。綜述了目前國內(nèi)外藥典收載的雙級液體撞擊器、多級液體撞擊器、馬普爾-米勒撞擊器、安德森級聯(lián)撞擊器、新一代撞擊器等撞擊器的主要結(jié)構(gòu)以及應(yīng)用情況。

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.

國家科技部重大專項(xiàng)（2017ZX09201002）