依鲁替尼胶囊处方的筛选研究

Study on Screening of Ibrutinib Capsules Formulation

目的:对依鲁替尼胶囊的处方进行筛选,获得合适的辅料用量。方法 :采用正交设计法分别考查崩解剂、表面活性剂和润滑剂,以溶出度为主要考查指标。结果:辅料中影响胶囊溶出度的主要因素是十二烷基硫酸钠,最优处方组成为交联羧甲基纤维素钠13.2mg,十二烷基硫酸钠13.2mg,硬脂酸镁1.8mg。结论:采用本处方可生产出符合质量要求的产品。

Objective：To get the appropriate amout of excipients,screen the formulation of ibrutinib capsules.Methods：Orthogonal method was performed in order to choose suitable disintegrant,surfactant,lubricant by using dissolution as indexes.Results：The experimental results indicated sodium lauryl sulfate was the chief factor of influencing dissolution of ibrutinib capsules.The optimum formulation was composed of croscarmellose sodium 13.2mg,sodium lauryl sulfate 13.2mg,magnesium stearate 1.8mg. Conclusion：The optimum formulation are reliable.