甲磺酸酚妥拉明分散片的处方筛选及质量控制

Preparation and quality investigation of dispersible phentolamine mesylate tablets

目的 :利用普通制剂技术制备起效快、服用方便的甲磺酸酚妥拉明分散片。方法 :用正交实验设计方法对处方工艺进行筛选与优化制成甲磺酸酚妥拉明分散片 ,并建立质量标准 ,进行溶出度、稳定性考察。结果 :甲磺酸酚妥拉明分散片处方合理、工艺简单、溶出快、稳定性好 ,符合中国药典 2 0 0 0年版质量标准。结论 :本品可作为医院制剂开发。

OBJECTIVE To prepare a fast action and easy administration dispersible phentolamine mesylate tablets using co-mmon technology.METHODS The formulation and preparation technique were selected by orthogonal method.The quality stan-dard was established. The dissolution and stability were studied.RESULTS The selected formulation and preparation technique are good.The dispersible tablets have a fast dissolution and good stability.The quality conforms to the stand of CHP (2000).CONCLUSIONS The dispersible table could be used conveniently for clinic.