医药导报2025，Vol.44Issue(11)：1778-1783,6.DOI:10.3870/j.issn.1004-0781.2025.11.009
激光衍射法测定中/长链脂肪乳注射液(C8～24Ve)粒度
Determination of the Particle Size of Medium and Long Chain Fat Emulsion Injection(C8～24Ve)by Laser Diffraction Method
摘要
Abstract
Objective To establish a laser diffraction method for determining globule size distribution in medium and long chain fat emulsion injection(C8～24Ve).Methods The Mastersizer 3000 laser particle size analyzer and Hydro EV wet sampling device were used,with water as the dispersion medium.Critical parameters,including refractive index,absorption coefficient,obscuration,measurement duration,stirring speed,and sonication parameters,were systematically optimized.Comparative evaluations were conducted across different computational models(Mie vs.Fraunhofer theories)and instrument platforms.Results The optimized optical parameters for particle size distribution analysis of medium and long chain fat emulsion injection(C8～24Ve)were determined as follows:absorption rate 0.001,refractive index 1.52,measurement duration 10 s,stirring speed 1 200 r·min-1,with no sonication applied.Under these conditions,the method demonstrated satisfactory precision,repeatability,and robustness.Conclusions This method demonstrates operational simplicity,high accuracy,and excellent reproducibility,making it suitable for particle size distribution analysis of medium and long chain fat emulsion injection(C8～24Ve).The established protocol provides a valuable reference for the development of particle size determination methods for emulsion formulations.关键词
中/长链脂肪乳注射液(C8～24Ve)/乳状注射液/粒度分布/激光衍射法Key words
Medium and long chain fat emulsion injection(C8～24Ve)/Emulsion injection/Particle size distribution/Laser diffraction method分类
医药卫生引用本文复制引用
薛巧如,陈华,欧爱萍,吴慧,谢兰桂,邓锋..激光衍射法测定中/长链脂肪乳注射液(C8～24Ve)粒度[J].医药导报,2025,44(11):1778-1783,6.基金项目
国家药典委员会2023年度国家药品标准制修订研究课题(2023Y05) （2023Y05）
新型雾化装置和仿生技术在吸入液体制剂中的研究及应用(2024SKLDRS0213). （2024SKLDRS0213）
