摘要
为优选辛伐他汀片的处方工艺并考察其稳定性,根据辅料相容性结果,采用正交设计试验,以多指标(休止角、含量及有关物质)综合评分法筛选最佳处方。以乳糖和微晶纤维素为填充剂,交联PVP为崩解剂,PVP(K30)为黏合剂,BHA为抗氧剂,微粉硅胶为助流剂,硬脂富马酸钠为润滑剂,采用粉末直接压片工艺。结果表明,优选的辛伐他汀片处方工艺合理,成品质量稳定。
To optimize the formulation and technology of simvastatin tablets and investigate its stability,the formula is optimized by using orthogonal design and multi-index（repose angle,content and related substances） comprehensive score.The excipient compatibility is observed.With lactose and MCC as fillers,PVPP as disintegrant,PVPK30 as adhesive,BHA as antioxidants,silica gel as flow aid and sodium stearyl fumarate as lubricant,direct powder compression is selected.The preparation process is simple and reasonable,and the quality of the products is stable.
出处
《河北工业科技》
CAS
2011年第1期30-32,共3页
Hebei Journal of Industrial Science and Technology
关键词
辛伐他汀
处方工艺
正交试验
simvastatin
formulation and technology
orthogonal test
