通脉复方微丸多元释药系统中葛根黄酮速释单元的制备工艺研究  

Study on the preparation craft of flavone of radix puerariae fast release unit in multi-drug delivery system of Tongmai micro-pellets

作　　者：陈斌[1] 萧伟[2] 黄洋[1] 贾晓斌[1] 

机构地区：[1]江苏省中医药研究院中药新型给药系统重点实验室,国家中医药管理局中药释药系统重点研究室,江苏南京210028 [2]中药制药过程新技术国家重点实验室,江苏康缘药业股份有限公司,江苏连云港222001

出　　处：《中国医院药学杂志》2012年第16期1243-1248,共6页Chinese Journal of Hospital Pharmacy

基　　金：江苏省中医药局中医药科技技术研究专项(编号: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(编号:2011NDDCM01002);中药制药过程新技术国家重点实验室开放课题(编号:SKL2010Z0303)

摘　　要：目的:制备葛根黄酮速释微丸,并对其制备工艺进行研究。方法:首先以熔融法将葛根黄酮组分制备成固体分散体,考察了载体及其比例对溶出度的影响。以葛根黄酮固体分散体作为主药制备微丸,考察了处方中润湿剂、载药量、辅料等因素对葛根黄酮微丸收率、圆整度、溶出度的影响;采用正交试验设计,筛选出葛根黄酮速释微丸的最佳制备工艺。结果:葛根黄酮速释微丸处方为主药20 g,乳糖5 g,微晶纤维素25 g,润湿剂为30%的乙醇。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30 Hz,滚圆时间6 min。结论:葛根黄酮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 flavone of radix puerariae fast release micro-pellets and study its preparation craft.METHODS First,flavone of radix puerariae was prepared for solid dispersion using fusion method.The influence of carrier and proportion on dissolution was investigated.Flavone of radix puerariae solid dispersion as principal agent was prepared for micro-pellets.The facts which can impact yield,extrude shaping,dissolution of flavone of radix puerariae micro-pellets such as wetting agent,drug loading dose,adjuvants were investigated.The optimum preparation craft of flavone of radix puerariae fast release micro-pellets was screened out by orhogonal design.RESULTS Formula of flavone of radix puerariae fast release micro-pellets is principal agent 20 g,lactose 5 g,MCC 25 g,30%ethanol as wetting agent.The extrusion-spheronization was applied.The optimum conditions were screened out as extrusion frequency（25 Hz）,spheronization machine frequency（30 Hz）,spheronization time（6 min）.CONCLUSION The process was scientific and rational.The preparation which is stable settles the basis for multi-drug delivery system of Tongmai micro-pellets.

关 键 词：通脉复方微丸多元释药系统 葛根黄酮速释单元 固体分散体 挤出滚圆 正交设计 

分 类 号：R943[医药卫生—药剂学]