苯海明口腔崩解片的制备

Preparation of Dimenhydrinate Orally Disintegrating Tablets

目的以MCC、PVPP和泡腾剂为崩解剂制备茶苯海明口腔崩解片。方法以聚丙烯酸树脂E100为载体制备茶苯海明包合物以掩蔽其苦麻味,采用粉末直接压片法制备片剂,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MCC5.3%、PVPP8.1%、泡腾剂15.6%。与市售普通片比较,口腔崩解片具有明显速释效果。结论将茶苯海明制成口腔崩解片能显著提高其体外溶出速度。

Aim To prepare orally disintegrating tablets of dimenhydrinate with MCC,PVPP and effervescent as the disintegrating agent. Methods Grains which contain dimenhydrinate and eudragit El00 were prepared in order to mask the bitterness of the dimenhydrinate. The tablets were prepared out of powder by direct compression and the formulation was optimized by central composite design and response surface methodology. The in vitro dissolution of the tablets was also evaluated. Results When fitted by binomial, using the content of MCC ,PVPP and effervescent as independent variables, and in vitro dissolution time as the dependent variable, the equation achieved had good coefficient. The optimizedformulation was MCC 5.3 % , PVPP 8.1% and effervescent 15.6%. The orally disintegrating tablets had better fast release effect than marketed tablets. Conclusion The in vitro dissolution rate of dimenhydrinate can be improved if the formulation of orally disintegrating tablets is used.