摘要
固体分散体是提高难溶性药物溶解度的有效方法之一,但是固体分散体中高度分散的药物通常处于无定形态,具有转化为稳定结晶的趋势,使其失去固体分散的特性。因此,监测固体分散体在贮存过程中药物存在状态及结晶度的变化,是固体分散体稳定性研究的重要内容。目前,已有多种定性方法用于监测固体分散体在存储过程中药物状态及结晶度的变化,并将这些定性分析方法与化学计量学相结合,进行定量分析。本文综述了近年来有关固体分散体中药物状态及结晶度的定性定量分析方法,为固体分散体的稳定性研究提供指导。
Solid dispersion is one of the most effective methods to improve the solubility of insoluble drugs.However,highly dispersed drugs in solid dispersion usually exist in an amorphous form and tend to be transformed into stable crystal,making them lose the property of solid dispersion.Therefore,monitoring drug status and change of crystallinity in solid dispersions during storage is an important research topic in the study of solid dispersion stability.At present,several qualitative methods have been used to monitor drug status and crystallinity of solid dispersions during storage,and these methods are carried out for quantitative analysis combined with stoichiometry.In this paper,the qualitative and quantitative analysis methods of drug state and crystallinity in solid dispersions used in recent years are reviewed,which will provide guidance for the study of solid dispersion stability.
作者
张俊芳
赵国巍
蔡萍
欧丽泉
梁新丽
董伟
王震洋
ZHANG Jun-fang;ZHAO Guo-wei;CAI Ping;OU Li-quan;LIANG Xin-li;DONG Wei;WANG Zhen-yang(Ministry of Education Key Laboratory for Modern Preparations of Chinese Medicine,Jiangxi University of Chinese Medicine,Nanchang 330004,China;College of Pharmacy,Jiangxi University of Chinese Medicine,Nanchang 330004,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第13期1282-1287,共6页
Chinese Journal of New Drugs
基金
江西省教育厅科学技术研究项目(GJJ201233)
江西中医药大学博士科研启动基金资助项目(2019WBZR001)
江西中医药大学校级研究生创新专项资金资助项目(JZYC21S44)。
关键词
固体分散体
结晶度
化学计量学
定性定量方法
solid dispersion
crystallinity
chemometrics
qualitative and quantitative determination
