吸入制剂空气动力学粒径分布测定法浅析

发布时间：2018-03-19 05:25

本文选题：吸入给药　切入点：体外评价　出处：《中国新药杂志》2017年12期 　论文类型：期刊论文

【摘要】：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。
[Abstract]:Determining the particle size of inhaled preparations is an important method to determine the aerodynamic distribution of particles in the respiratory system. The methods of particle size determination are cascade impactor method, laser diffraction method, Time of Flight Spectrometry, etc., although the cascade impactor determination process is cumbersome and time-consuming, it is internationally recognized, This paper reviews the determination of aerodynamics particle size distribution of inhaled preparations by cascade impactor method, including the principle and data evaluation of the method. The applicability and variability of different inhaled preparations to this method.
【作者单位】：中国食品药品检定研究院;
【基金】：国家“重大新药创制”科技重大专项资助项目(化药制剂质量评价关键技术研究,吸入制剂有效性评价方法研究,2015ZX093001002009)
【分类号】：R927.1

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