α-2b干扰素鼻用喷雾剂的制备及其对黏膜纤毛毒性的研究  

Preparation and ciliotoxicity of interferon a-2b nasal spray

作　　者：杨丽[1] 翟所迪[1] 

机构地区：[1]北京大学第三医院药剂科,北京100083

出　　处：《中国新药杂志》2006年第5期357-360,共4页Chinese Journal of New Drugs

摘　　要：目的:制备α-2b干扰素鼻用喷雾剂,并研究其对鼻腔黏膜纤毛的毒性。方法:按正交试验设计优化处方,制备α-2b干扰素鼻用喷雾剂,考察其初步稳定性,并采用在体蟾蜍上腭模型法,研究α-2b干扰素鼻用喷雾剂、空白鼻用喷雾剂和干扰素溶液对鼻黏膜纤毛的影响,分别计算纤毛持续摆动时间的相对百分率。结果:自制α-2b干扰素鼻用喷雾剂稳定性良好,α-2b干扰素溶液、空白鼻用喷雾剂和含药鼻用喷雾剂对蟾蜍上腭纤毛持续摆动时间的相对百分率分别为99．2%,90．0%和85．7%,与阴性对照(1%盐酸麻黄素溶液)均无显著性差异(P＞0．05),表明自制α-2b干扰素鼻用喷雾剂对蟾蜍上腭纤毛运动基本无影响。结论:自制α-2b干扰素鼻用喷霉剂的物理化学性质优良,稳定性良好,对黏膜纤毛的毒性较小,有望用于鼻腔给药。Objective：To prepare interferon α-2b nasal spray and assess its nasal mucomembranous ciliotoxicity. Methods ： The optimal formula and stability assessment of the nasal spray was conducted by an orthogonal protocol. Using a toad palate in situ mode, the effect of the interferon ct-2b nasal spray on the nasal mucomembranous cilia was compared with the ones of a blank nasal spray and interferon solution. The lasting time of ciliary movement （LTCM） was recorded using an optical microscope before and after drug application. Results：The interferon α-2b nasal spray remained stable for 3 months at 4 ℃. The interferon α-2b nasal spray, the blank nasal spray and the interferon solution showed a relative percentage for LCTM of 99.2% ,90.0% and 85.7% , respectively, which had no significant difference from the negative control （ 1% pseudoephedrine solution） （ P 〉 0.05 ）. Conclusion： The self-made interferon α-2b nasal spray showed less ciliotoxicity. Further clinical evaluation for the human nasal mucomembranous ciliary irritation is warranted.

关 键 词：干扰素 鼻用喷雾剂 纤毛毒性 

分 类 号：R944.7[医药卫生—药剂学] R341.1[医药卫生—药学]