豆腐果苷口腔崩解片的制备

 目的以微晶纤维素(MCC),交联聚乙烯吡咯烷酮(PVPP)和泡腾剂(碳酸氢钠与枸橼酸比例为1∶1.2)为崩解剂制备豆腐果苷口腔崩解片。方法采用粉末直接压片法制备,运用星点设计-效应面法进行处方优化,并对药物体外溶出进行评估。结果以MCC,PVPP和泡腾剂含量为自变量,体外崩解时间为因变量进行二次多项式拟合,结果表明,拟合的效果较好,较优处方为MCC 5.4%、PVPP 5.8%、泡腾剂12%。与市售普通片比较,口腔崩解片具有明显速释效果。结论将豆腐果苷制成口腔崩解片能显著提高其体外溶出速度。

Preparation of Helicid Orally Disintegrating Tablets

OBJECTIVE To prepare orally disintegrating tablets of helicid with MCC,PVPP and effervescent as disintegrating agent.METHODS The tablets were prepared by direct compression from powder,and the formulation was optimized by central composite design and response surface methodology.The in vitro dissolution of the tablets was also evaluated.RESULTS Using thecontent of MCC,PVPP and effervescent as independent variable,and in vitro dissolution time as dependent variable,the equation achieved had good coefficient.The optimized formulation was MCC 5.4%,PVPP 5.8% and effervescent 12%.The orally disintegrating tablets had significant fast release effect,compared with marketed tablets.CONCLUSION The in vitro dissolution rate of helicid can be improved using the formulation of orally disintegrating tablets.