激光衍射法测定西格列他钠粒径分布  

Determination of particle size distribution of chiglitazar sodium by laser diffraction method

作　　者：郭宁子 刘丽[1] 岳瑞齐 冯慧庆 杨化新[1] 魏宁漪[1] 陈华[1] GUO Ningzi;LIU Li;YUE Ruiqi;FENG Huiqing;YANG Huaxin;WEI Ningyi;CHEN Hua(National Institutes for Food and Drug Control,Beijing 102629,China;Chinese Pharmacopoeia Commission,Beijing 100061,China;Malvernpanalytical Co.,Ltd.,Beijing 100040,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药典委员会,北京100061 [3]马尔文帕纳科有限公司,北京100040

出　　处：《中国药物警戒》2024年第2期147-151,共5页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划(2023YFC2410202)。

摘　　要：目的建立西格列他钠的粒径分布测定方法,为药物粒径测定的方法开发和质量控制提供参考。方法采用MALVERN Mastersizer 3000激光衍射粒度仪和AEROS干法进样器建立西格列他钠的粒径分布方法。背景测量持续时间7 s;样品测量持续时间7 s;遮光度0.5%~5%;样品分散气压0.4 MPa;进样速度60%;文丘里管类型为高能文丘里管;料斗间隙2.5 mm。结果3批样品粒径分布特征值d(0.1)在1.02~1.17μm,d(0.5)在5.94~6.69μm,d(0.9)在20.70~22.40μm,平均标准偏差(RSD)均小于1%。结论建立了西格列他钠的粒度测定方法,可为其他易引湿药物的干法粒径测定方法开发提供参考。Objective To establish a laser diffraction method for determination of the particle size distribution of chiglitazar sodium so as to provide reference for the development and quality control of methods for determination of drug particle size.Methods The Malvern Mastersizer 3000 laser particle size analyzer with an AEROS dry sampler was used to establish a laser diffraction method for determination of the particle size distribution of chiglitazar sodium.As for the AEROS injector,the conditions of determination were as follows:the duration of background measurement was 7 s,the duration of sample measurement was 7 s,obscuration ranged from 0.5%to 5%,the sample dispersion pressure was 0.4 MPa,the injection speed was 60%,high energy venturis were used,and the hopper gap was 2.5 mm.Results The particle size distribution value of the three batches of samples ranged from 1.02 to 1.17μm in d(0.1),5.94 to 6.69μm in d(0.5),and 20.70 to 22.40μm in d(0.9).The RSD of the above values was below 1%.Conclusion A particle size determination method has been established for chiglitazar sodium,which can provide reference for the development of dry particle size determination methods for other hygroscopic drugs.

关 键 词：激光衍射法 西格列他钠 粒径分布 易引湿药物 干法测定 

分 类 号：R927.1[医药卫生—药学]