建立依帕司他原料粒度检测方法的质量控制措施  

Quality Control Measures of Epalrestat Raw Material Particle Size Testing Method Were Established

作　　者：冯小雪 薛雯蔚 尤锐 FENG Xiaoxue;XUE Wenwei;YOU Rui(Yangtze River Pharmaceutical Group Nanjing Hailing Pharmaceutical Co.,Ltd.,Nanjing 210049,China)

机构地区：[1]扬子江药业集团南京海陵药业有限公司,江苏南京210049

出　　处：《化工管理》2024年第8期66-68,共3页Chemical Engineering Management

摘　　要：采用依帕司他原料粒度和粒度分布测定方法,探索并进行方法学研究,对折射率、分散压力、进样速率等参数进行确定,并对最终建立的粒度和粒度分布测定方法进行重复性试验、中间精密度试验、耐用性试验等方法学考察,结果显示:折射率、分散压力、进样速率等参数均符合标准规定,方法良好。建立的激光粒度法(干法)适用于依帕司他原料粒度及粒度分布测定,可用于相关医药制剂的研发及生产的质量控制。Epalrestat raw material particle size and particle size distribution measurement method was used to explore and conduct methodological research,and parameters such as refractive index,dispersion pressure and injection rate were determined.The final established particle size and particle size distribution measurement method was investigated by means of repeatability test,intermediate precision test and durability test.The results showed that:The index of refraction,dispersion pressure,injection rate and other parameters are in line with the standard,and the method is good.The laser particle size method(dry method)is suitable for the determination of the particle size and particle size distribution of epalrestat raw materials,and can be used for the quality control of the development and production of related pharmaceutical preparations.

关 键 词：粒度分布 光散射法 依帕司他 医药化工 

分 类 号：R917[医药卫生—药物分析学]