盐酸多奈哌齐冻干口崩片的处方工艺研究及体外评价

Study on Formulation and in Vitro Evaluation of Donepezil Hydrochloride Freeze-dried Orally Disintegrating Tablets

目的:制备盐酸多奈哌齐口崩片,并评价其质量。方法:以崩解时限和口感为指标因素,并通过冷冻干燥工艺将其制备成口崩片,通过正交设计试验,筛选最优处方与工艺,并进行了体外溶出度检测。结果:经试验优化后得到的盐酸多奈哌齐口崩片,崩解时间更短,溶出度更高,口感更好。结论:盐酸多奈哌齐口崩片处方工艺合理,成品质量稳定。

Objective:To explore the formulation and of Donepezil Hydrochloride orally disintegrating tablets,and evaluate them.Methods:The formulation was optimized with disintegration time,taste and dissolution as the main indicators,then prepared into disintegrating tablets by freeze-drying process,an orthogonal design was applied and The dissolution in vitro was tested.Results:The optimized orally disintegrating tablets had the shorter disintegration time,higher dissolution rate and better taste.Conclusion:The preparation process is reasonable,and the quality of the products is stable.