摘要
目的:优选丹参酮缓释微丸制备工艺。方法:将丹参酮组分制备成缓释固体分散体,考察乙基纤维素、羟丙甲基纤维素对其溶出度的影响;以丹参酮固体分散体作为主药制备微丸,考察处方中润湿剂、载药量、辅料、乳糖、润湿剂等因素对丹参酮微丸收率、圆整度的影响;采用正交试验设计筛选出丹参酮缓释微丸的最佳制备工艺。结果:丹参酮组分制备成缓释固体分散体,处方为乙基纤维素-丹参酮组分-羟丙甲基纤维素(3∶1∶0.5);以固体分散体为主药制备成微丸,处方为丹参酮固体分散体20 g,乳糖6 g,微晶纤维素24 g,润湿剂为水33 mL,最佳工艺条件为挤出频率25 Hz,滚圆频率50 Hz,滚圆时间6min。结论:本工艺科学合理,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 tanshinone release pellets and research its preparation technology.Method：Tanshinone was prepared for release solid dispersion,influence of ethyl cellulose（EC） and hydroxypropyl methyl cellulose（HPMC） in different dosage on dissolution was investigated;Tanshinone solid dispersion as principal agent was prepared for pellets,effects of wetting agent,drug loading dose,accessories,lactose,wetting agent dose and other factors from prescription on yield and roundness of tanshinone were investigated;Optimum preparation technology of tanshinone release pellets was screened out by orhogonal design.Result：Tanshinone was prepared for release solid dispersion,prescription was tanshinone-EC-HPMC 1∶3∶0.5;Pellet was prepared by solid dispersion as principal agent,Formulation was tanshinone solid dispersion 20 g,lactose 6 g,MCC 24 g,33 mL water as wetting agent,optimum technology conditions were：extrusion frequency 25 Hz,rounded frequency 50 Hz,spheronization time 6 min.Conclusion：This process was scientific and rational,preparation was stable,it settled basis for preparation of multi-drug delivery system of Tongmai compound pellets.
出处
《中国实验方剂学杂志》
CAS
北大核心
2012年第4期39-42,共4页
Chinese Journal of Experimental Traditional Medical Formulae
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
丹参酮缓释单元
固体分散体
挤出滚圆
正交设计
multi-drug delivery system of Tongmai compound pellets
tanshinone release unit
solid dispersion
extrusion spheronization
orhogonal design
