盐酸左西替利嗪冻干口崩片的制备

Preparation of Leoxitirizine Hydrochloride Lyophilized Orally Disintegrating Tablets

目的:设计盐酸左西替利嗪冻干口崩片的制备工艺并评价成品质量。方法:采用冷冻干燥法制备盐酸左西替利嗪冻干口崩片,以成品外观、崩解时限、口感口味等为指标对口崩片质量进行单因素考察,并通过正交试验优化处方。结果:口崩片最优处方:盐酸左西替利嗪-β-环糊精包合物每片11.25 mg、甘氨酸每片10 mg、普鲁兰多糖每片8 mg、三氯蔗糖每片0.5 mg、白桃香精每片1.5μL;最终制备得到外观优美、崩解迅速、口味良好的盐酸左西替利嗪冻干口崩片。结论:盐酸左西替利嗪冻干口崩片制备工艺稳定可靠,可用于大规模生产。

Objective:To design the preparation technology of leoxitirizine hydrochloride lyophilized orally disintegrating tablets by freeze drying method and evaluate its quality.Methods:Levocetirizine hydrochloride lyophilized orally disintegrating tablets were prepared by freeze-drying method.The appearance,disintegration time and taste of the finished products were investigated by single factor,and the prescription was optimized by orthogonal experiment.Results:The optimal prescription of leoxitirizine hydrochloride orally disintegrating tablets were levocetirizine-β-cyclodextrin inclusion complex 11.25 mg per tablet,glycine 10 mg per tablet,pullulan 8 mg per tablet,sucralose 0.5 mg per tablet,white peach flavor 1.5μL per tablet.Leoxitirizine hydrochloride lyophilized orally disintegrating tablets with beautiful appearance,quick disintegration in the mouth and good taste were prepared.Conclusion:The preparation process of leoxitirizine hydrochloride lyophilized orally disintegrating tablets is stable and reliable,which can be used for large-scale production.