摘要
D-甘露醇(1)的粒子形态可能会影响其理化特性及功能指标。本研究通过对1粒子的形态、晶型变化、粉体学性能、水分吸附性能进行考察,探讨1颗粒的形貌对其性质与功能的影响。结果表明,1的颗粒形貌能够在一定程度上影响其可压性、流动性等功能指标及水分吸附能力等性质。这提示在制剂开发前期的辅料筛选过程中,应关注不同晶型及制粒工艺对1性质及功能的影响,以保证1制剂质量的稳定性。
The particle morphology of D-mannitol(1) may affect its physicochemical properties and functional indicators.In this study,the morphology,crystal form changes,powder properties,and moisture adsorption properties of 1 particles were investigated,and the influence of 1 particle morphology on its properties and functions was discussed.The results showed that the particle morphology of 1 could affect its compressibility,fluidity and other functional indicators,as well as water adsorption capacity and other properties,which suggested that during the screening of excipients in the early stage of formulation development,attention should be paid to the effects of different crystal forms and granulation processes on the properties and functions of 1 to ensure the stability of formulation quality.
作者
余少文
郭雅娟
胡淑君
陈英
YU Shaowen;GUO Yajuan;HU Shujun;CHEN Ying(NMPA Key Lab.of Quality Control and Evaluation of Pharmaceutical Excipients,Guangdong Institute for Drug Control,Guangzhou)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2022年第3期360-366,共7页
Chinese Journal of Pharmaceuticals
基金
广东省科技项目——广东省生物医药科技协同创新中心(2018B020207008)。
关键词
D-甘露醇
颗粒形貌
流动性
可压性
D-mannitol
particle morphology
fluidity
compressibility