复方小叶枇杷分散片的制备及质量评价

Preparation and Quality Evaluation of Fufangxiaoyepipa Dispersible Tablets

目的:研究复方小叶枇杷分散片的制备,并进行质量评价。方法:以崩解时限为指标,采用正交试验,对复方小叶枇杷分散片处方进行优化。结果:处方组成为40%混合浸膏粉、15%微晶纤维素、18%交联羧甲基纤维素钠、25%硫酸钙、2%硬脂酸镁,压片后崩解时限符合药典要求。结论:所选处方合理,崩解快,分散均匀性好。与普通片比较,小叶枇杷分散片体外溶出度高,提高了制剂的生物利用度。

Objective： To study the preparation of fufangxiaoyepipa dispersible tablets and evaluate its quality.Methods： Using the disintegration time as index to screen out the best prescription of the dispersible tablets by orthogonal design.Results： The prescription assembly was 40% of extraction,15% of MCC,18% of CCMC-Na,25% of Calcium sulfate,2% of Magnesium stearate,the disintegration time met the provision of Pharmacopoeia.Conclusion： The dispersible tablets dissolve faster and disperse uniformly and the dissolution percent in vitro is obviously superior to the conventional tablets,improving the bioavailability of the preparation.