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
Key words
particle size distribution/light scattering method/epalrestat/pharmaceutical and chemical industry