恩替卡韦分散片的处方工艺研究

Formulation and Technology of Entecavir Dispersible Tablets

目的研究恩替卡韦分散片的处方工艺。方法根据辅料相容性结果,采用正交实验法,将辅料的用量和加入方法作为考察因素,筛选出恩替卡韦分散片处方中乳糖、微晶纤维素、羧甲淀粉钠、硬脂酸镁、阿司帕坦和甜橙香精的最佳配比。结果确定了恩替卡韦分散片处方:乳糖70g,微晶纤维素20g,10%的聚维酮溶液用量为15mL,崩解剂用量为7g,崩解剂加入方式为外加。结论所选恩替卡韦分散片的处方合理,工艺简单。

OBJECTIVE To optimize the formulation and technology of entecavir dispersible tablets. METHODS Orthogonal test was used to screen the optimum proportion of lactose,MCC,carboxymethyl starch sodium,magnesium stearate,aspartame and melit-orange essence etc. The adjuvant compatibility was also observed. RESULTS According to the results of the single factor analysis and orthogonal test,the optimal condition of entecavir dispersible tablets were as follows：lactose 70 g,MCC 20 g,10% PVP 15 mL,disintegrating agent 7 g. The disintegrating agent was extrinsic added. CONCLUSION This preparation of entecavir dispersible tablets is reasonable,and the technology is simple.