Study on the Influence of Ultrasound Parameters on the Determination of Particle Size and Particle Size Distribution of Budesonide Suspension for Inhalation by Laser Diffraction Method
10.3870/j.issn.1004-0781.2025.11.010
- VernacularTitle:激光衍射法超声参数对测定吸入用布地奈德混悬液粒度与粒度分布结果的影响
- Author:
Dong CHENG
1
;
Minhua XUE
1
;
Jing YIN
1
;
Xuhua QIU
1
;
Mengyuan LIU
1
;
Yihong LU
1
Author Information
1. 江苏省药品监督检验研究院,南京 210019
- Publication Type:Journal Article
- Keywords:
Budesonide suspension for inhalation;
Laser diffraction method;
Ultrasonic parameters;
Particle size;
Particle size distribution;
FlowCam
- From:
Herald of Medicine
2025;44(11):1784-1788
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study the influence of laser diffraction ultrasound parameters on the determination of particle size and particle size distribution of budesonide suspension for inhalation,and explore the rationality of ultrasound parameter settings of the laser diffraction method.Methods The Mastersizer 3000 was set to measure the particle size and particle size distribution of budesonide suspension for inhalation from 6 companies at different ultrasonic times,and the FlowCam was used to test the samples simultaneously.Results The ultrasound parameters have a significant impact on the particle size and particle size distribution of budesonide suspension for inhalation in some companies,and the FlowCam test results show that particles in some samples exhibit aggregation,which can be dispersed by ultrasound and affect the results.Conclusion It is necessary to optimize the ultrasound parameters of laser diffraction to determine the particle size and particle size distribution of suspension for inhalation,and verify the rationality of the ultrasound parameter settings through microscopic techniques.
