盐酸左西替利嗪冻干口崩片的制备OACSTPCD

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 1.5 μL 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.