摘要
通过处方筛选和工艺优化,解决辛伐他汀不稳定,极易发生降解等问题。从辛伐他汀的降解途径入手,根据辅料相容性试验、正交试验设计确定辅料用量;同时,对不同制粒工艺的进行比较考察。变更了处方工艺,新处方中添加了维生素C,调整各个辅料的用量,并由干法制粒改为湿法制粒工艺。试验结果表明,辛伐他汀片新处方合理,各项指标无显著变化,新处方工艺适用于大生产。
The instability and prone to degradation of simvastatin were resolved through formulation and process optimization.The orthogonal experiment of accessories compatibility test was designed to determine the amount of accessories.At the same time,different granulation processes were conducted comparatively.The prescription process was changed by addition of vitamin C and the amount of various accessories,simultaneously,and dry granulation was instead of wet granulation process.Results showed that a reasonable prescription of Simvastatin Tablets was established,and it was suitable for large-scale production for there were no significant changes in the various indicators.
出处
《广州化工》
CAS
2013年第2期58-61,共4页
GuangZhou Chemical Industry
关键词
辛伐他汀片
降解途径
处方筛选
工艺优化
Simvastatin Tablets
degradation pathway
formulation optimization
process optimization
