芍药苷胃漂浮片处方工艺优选

Optimization of Formulation Technology for Gastric Floating Tablets from Paeoniflorin

目的:优选芍药苷胃漂浮片处方工艺。方法:采用湿法制粒压片法制备芍药苷胃漂浮片,以漂浮性能和体外释放度为评价指标,通过单因素和正交试验确定漂浮片最佳工艺处方。结果:最佳工艺为芍药苷80.00mg,HPMC K15M 45.00mg,NaHCO345.00mg,PVPP 20.00mg,十八醇30.00mg,MCC135.00mg;起漂时间<1min,持漂时间>12h,体外释放行为符合药典规定。结论:采用最佳工艺制备的芍药苷胃漂浮片具有优良的漂浮能力和释药行为,使芍药苷在胃内的滞留时间延长,生物利用度提高。

Objective： To optimize formula of gastric floating tablets of total glucosides from paeoniflorin .Methods： Gastric floating tablets were prepared by compression with wet legal system grain .With floating properties and in vitro release as indexes,single factor tests and orthogonal design test were adopted to optimize formulation parameters .Results： Optimum formulation included 80.00mg paeoniflorin, 45.00mg HPMC K15M,45.00mg NaHCO3 ,20.00mg PVPP,30.00mg octa-decanol, 135.00mg MCC.The results showed that these products could float within 1min and maintain for over 12h,in vitro release of this tablets was in accordance with the Chinese Pharmacopoeia demands .Conclusion： These prepared gas-tric floating tablets showed a good sustained -release and continual floating property .It could increase residence time and improve biological availability.