马来酸曲美布汀胃漂浮缓释片的处方筛选及体外评价

目的筛选马来酸曲美布汀胃漂浮缓释片的处方,并评价其漂浮和体外释放特性。方法用正交实验设计对片剂处方进行筛选与优化,制备马来酸曲美布汀胃漂浮缓释片,测定其体外释药与漂浮特性。结果优选的处方为每片含HPMC800030 mg,CMC-Na 30 mg,十六醇70 mg,CaCO330 mg。该处方片剂在硬度为3-4 kg时漂浮性好,体外持续释药达6 h以上,符合Higuchi模型。结论该片剂具漂浮、缓释作用,制备工艺简单。

Formula optimization of trimebutine maleate floating sustained-release tablets and evaluation in vitro

Objective To optimize the formula of trimebutine maleate floating tablets and to evaluate its buoyant and drug release property in vitro. Methods Orthogonal design was used to select the optimal formula of the tablet, the buoyant and drug release property in vitro were also observed. Results The optimal formula included HPMC8000 30 mg, CMC-Na 30 mg, cetyl alcohol 70 mg and CaCO3 30 mg. Tablets of this formula showed excellent buoyant property when the hardness was within 3-4 kg. The drug was sustainedly released in vitro over 6 hrs and the release rate conformed to Higuchi kinetics equation. Conclusion The tablet has a floating and sustained-release effect, and the preparation is simple.