TJ0711盐酸盐缓释片的制备及体外释放特性考察  

Preparation of TJ0711 hydrochloride sustained release tablets and evaluation of its in vitro drug release

作　　者：郭伟林[1] 胡洋[1] 胡磊[1] 徐晓龙[1] 吕振华[1] 斯陆勤[1] 黄建耿[1] 李高[1] 

机构地区：[1]华中科技大学同济医学院药学院,湖北武汉430030

出　　处：《中国医院药学杂志》2012年第12期936-939,共4页Chinese Journal of Hospital Pharmacy

基　　金：科技部重大新药创制"十一五"资助项目(编号:2009ZX09103-146);"十二五"资助项目(编号:2012ZX09102101-016);湖北省研究与开发计划项目(编号:2008 BCB103)

摘　　要：目的:研制TJ0711盐酸盐混合骨架缓释片,并评价其体外释放特性。方法:研究了HPMC的黏度和用量,十八醇、CMC-Na的用量对药物释放的影响,并通过正交试验设计对片剂的处方进行优化。结果:正交设计所得最优处方为十八醇、HPMC K4M、CMC-Na的用量分别为片重的20%,40%,10%。药物体外释放良好,符合Higuchi模型(Q=33.909t1/2-20.263,r=0.996 2),持续释药达12 h。结论:经正交优化的TJ0711盐酸盐缓释片处方可行。OBJECTIVE To prepare sustained-release TJ0711 hydrochloride tablets with several kinds of matrix materials and evaluate its release property in vitro. METItODS The effects of the viscosity of HPMC, amount of HPMC, stearyl alco- hol, CMC-Na were studied, using release rate of drug as marker. The formulation was optimized by the orthogonal design test. RESULTS The optimized prescription： amount of HPMC K4M, stearyl alcohol and CMC-Na were 40%, 20%, 10%, respec- tively. The release rate of this drug conformed to Higuchi equation （Q = 33. 909t1/2 - 20. 263, r = 0. 996 2） and the drug was sustained released in vitro within 12 h. CONCLUSION The formulation of TJ0711 hydroehloride sustained-release tablets is feasible.

关 键 词：TJ0711盐酸盐 缓释 正交设计 制备 释放度 

分 类 号：R944[医药卫生—药剂学]