卡托普利混合骨架片的处方筛选及优化

Formulation screening of Captopril mixed matrix tablets

目的 :研制混合骨架的卡托普利缓释片。方法 :采用两因素六水平的均匀设计法筛选混合骨架片的优化处方 ,其中 ,两因素为缓释骨架材料HPMCK4M和蜡质 888(Compritol 888) ;六水平指这两种缓释材料 6种不同的用量。结果 :最终优化处方中缓释材料HPMCK4M用量为 2 0 % ,Compritol 888用量为 30 %。 结论 :用优化的处方 ,工艺制备的 3批卡托普利缓释片体外释放良好 ,质量稳定。

OBJECTIVE Captopril sustained-release tablets with mixed matrix were prepared in this article. METHODS A two-factor-six-level uniform design was performed to sift screening the formulation in which the two factors were HPMC K4M and compritol 888 while the levels were different contents of these matrix materials. RESULTS The final optimal formula was that the content of HPMC K4M was 20% while compritol 888 30%. CONCLUSION The druy release of the Captopril sustained release tablets prepared according to this optimal formulation is good and the quality is stable.