氯雷他定鼻贴剂的制备及处方组成研究

Preparation and optimized formulation of loratadine nasal patch

目的:研究氯雷他定鼻贴剂的制备及其处方组成。方法:通过单因素考察,筛选氯雷他定鼻贴剂的背衬材料和基质浓度范围;采用L16(45)正交试验设计,以稳态渗透速率为考察指标,研究氯雷他定鼻贴剂的处方组成。结果:本研究自制氯雷他定鼻贴剂采用涂有压敏胶的医用无纺布作为背衬层材料;优化处方组成:PVA含量为5.0%,氮酮及冰片含量分别为2.5%、0.5%,甘油含量为10.0%;其稳态渗透率为(2.79±0.12)μg·cm^2/h。结论:制备的氯雷他定鼻贴剂外观及经皮渗透重现性均良好,工艺合理。

Objective：To study the preparation and formulation of loratadine nasal patch.Methods：The backing material and matrix concentration range of loratadine nasal patch were screened by single factor study.The formulation of loratadine nasal patch was investigated with L16（45）orthogonal design based on steady-state permeability rate.Results：The medical nonwoven fabric coated with pressure sensitive adhesive was used as the backing material.The optimum formulation was 5.0% PVA,2.5% ketone,0.5% borneol and 10.0% glycerol.The steady-state permeability rate of the nasal patch was（2.79±0.12）μg·cm^2/h with optimum formulation.Conclusion： The appearance and transdermal permeation reproducibility of loratadine nasal patch are excellent,and the process is reasonable.