摘要
目的:制备丹参酚酸速释微丸,并对制备工艺进行研究。方法:考察了处方中润湿剂、载药量、辅料、乳糖用量、崩解剂、羧甲基淀粉钠用量以及润湿剂用量等因素对丹参酚酸微丸收率、圆整度、溶出度的影响;采用正交试验设计,筛选出丹参酚酸速释微丸的最佳制备工艺。结果:丹参酚酸速释微丸处方以总量50 g计算,主药22.5g,乳糖5 g,羧甲基淀粉钠2 g,微晶纤维素20.5 g,润湿剂为30%的乙醇27 mL。采用挤出滚圆法制备,最佳工艺条件为挤出频率25 Hz,滚圆频率50 Hz,滚圆时间4 min。结论:丹参酚酸速释微丸制备工艺科学合理,制剂稳定,为通脉复方微丸多元释药系统的制备奠定了基础。
Objective：To prepare Danshen phenolic acid fast release micro-pellets and study its preparation craft.Methods： The factors which could impact yield,extrude shaping,dissolution of Danshen phenolic acid micro-pellets such as wetting agent,drug loading dose,adjuvant,lactose dose,disintegrant,CMS-Na dose and wetting agent dose was investigated.The optimum preparation craft of Danshen phenolic acid fast release micro-pellets was screened out by orhogonal design.Results： Formula of Danshen phenolic acid fast release micro-pellets was calculated as volume dose 50 g.The formula was as follows： principal agent 22.5 g,lactose 5 g,CMS-Na 2 g,MCC 20.5 g,27 mL 30%ethanol as wetting agent.Extrusion-spheronization was applied.The optimum conditions were screened out as follows：extrusion frequency（25 Hz）,spheronization machine frequency（50 Hz）,spheronization time（4 min）.Conclusion： The process was scientific and rational.The preparation is stable settles basis for multi-drug delivery system of Tongmai micro-pellets.
出处
《中药材》
CAS
CSCD
北大核心
2012年第7期1140-1143,共4页
Journal of Chinese Medicinal Materials
基金
江苏省中医药局中医药科技技术研究专项(LZ09061)
国家中医药管理局中药释药系统重点研究室开放基金课题(2011NDDCM01002)
中药制药过程新技术国家重点实验室开放课题(SKL2010Z0303)
关键词
通脉复方微丸多元释药系统
丹参酚酸速释单元
制备工艺
挤出滚圆
正交设计
Multi-drug delivery system of Tongmai micro-pellets
Danshen phenolic acid fast release unit
Preparation craft
Extrusion-spheronization
Orhogonal design
