吸入制剂空气动力学粒径分布测定法浅析

A review on the determination methods for the aerodynamic particle size distribution of the inhalation preparations

测定吸入制剂的粒径是确定粒子在呼吸道系统中空气动力学分布的重要方法。粒径测定的方法有级联撞击器法、激光衍射法、飞行时间光谱测定法等。尽管级联撞击器测定法步骤繁杂、耗时,但该测定法是国际公认、准确的方法并且是多国药典收载的法定方法。本文就采用级联撞击器法对吸入制剂进行空气动力学粒径分布的测定进行综述,包括该方法的原理和数据评估,不同吸入制剂对该方法的适用性及该方法的变异性。

Particle size of the orally inhaled drug products（ OIPs） is widely accepted as an important factor in determining the aerodynamic deposition of particles within the respiratory system. Methods used for the particle size determinationinclude cascade impactor（ CI）,laser diffraction（ LD）,and time of flight spectrometry. As an accurate compendium method,the CI-based methods for measuring the aerodynamic particle size distribution（ APSD） properties of OIP-produced aerosols are recognized by the regulatory agencies worldwide and adopted by various pharmacopoeias,although CI method is characterized by complex devices and time-consuming operations.The purpose of this review is to discuss the roles of CI in determining the APSD of OIPs,including its principle and data interpretation,suitability and variability of the CI method for the characterization of inhalation preparations.