摘要
无定型固体分散体是提高难溶性药物口服生物利用度的有效策略之一,应用前景广泛。但由于存在固态物理稳定性,即“老化”的问题,会影响药物的体外溶出和体内吸收,给无定型固体分散体制剂的开发带来了较大挑战。固态物理稳定性易受处方组成、制备工艺和贮存条件等多种因素的影响。文章讨论了无定型固体分散体制剂的处方组成、制备工艺和质量控制,以期为其研究和开发提供参考。
Amorphous solid dispersion is one of the most effective formulation approaches to enhance the oral bioavailability of poorly water-soluble drugs with wide application prospects.However,due to the"aging",a solid state physical stability problem,which affects the dissolution in vitro and absorption in vivo,the development of amorphous solid dispersion-based preparations faces great challenges.The solid state physical stability is affected by many factors such as formulation composition,preparation process and storage conditions.In this paper,formulation composition,preparation process and quality control of amorphous solid dispersion-based preparations are summarized in order to provide the guidance for the development of amorphous solid dispersion-based preparations.
作者
杨茜
李慧义
YANG Xi;LI Huiyi(Chinese Pharmacopoeia Commission,Beijing 100061)
出处
《中国医药工业杂志》
EI
CAS
CSCD
2024年第6期743-749,共7页
Chinese Journal of Pharmaceuticals
关键词
无定型固体分散体
处方
制备工艺
物理稳定性
质量控制
amorphous solid dispersion
formulation
preparation process
physical stability
quality control
