豚鼠及家兔rhIFNα-2b喷雾剂毒性试验与病理检查  

Pathological examination of toxicity test of guinea pig and rabbits sprayed with rhIFNα-2b

作　　者：李芳 王宝仁 赵晓青[2] 赵亚力[2] 周捷[2] 郑辉[2] 郭桥[2] 李晶[2] 

机构地区：[1]武警大连医院药械科,大连116013 [2]长春生物制品研究所,长春130062

出　　处：《武警医学》2009年第3期254-256,F0003,共4页Medical Journal of the Chinese People's Armed Police Force

摘　　要：目的观察rhIFNα-2b喷雾剂对豚鼠和家兔鼻腔黏膜是否具有刺激作用或伤害反应,同时观察其对上述动物内脏器官的毒性病理损伤。方法将rhIFNα-2b喷雾剂喷入豚鼠和家兔鼻腔进行局部刺激试验、急性毒性试验及长期毒性试验,各试验分别设空白对照组、稀释液对照组及实验组。长期毒性试验实验组按给药浓度不同分低、中、高3个剂量组。每组用4只动物,实验组给予rhIFNα-2b喷雾剂,稀释液对照组喷入喷雾剂稀释液,空白对照组未喷任何物质。临床观察后全部活杀。剖检鼻腔、咽部和喉部黏膜及内脏等器官,10%中性甲醛液固定,常规病理制片,光镜观察。结果鼻腔局部刺激试验、急性毒性试验及长期毒性试验中各实验组与稀释液和空白对照组之间的病理组织学所见相似,均未见明显毒性病理损伤。结论rhIFNα-2b喷雾剂对豚鼠和家兔的鼻腔黏膜及内脏器官均未见明显毒性作用,证实rhIFNα-2b喷雾剂具有可靠的安全性。Objective To observe whether the recombinated human interferon α-2b（ rhIFNα -2b） spray can stimulate or do harm to guineapigs＇ and rabbits＇ nasal cavity mucosa and to what toxic and pathological damages does rhIFNα -2b cause to the ani- mals. Methods Blank group, dilution control group, and experiment group were established, which were composed of four guinea pigs and rabbits each. rhIFNα -2b nebula was sprayed into guinea pig＇s and rabbit＇s nasa cavity in experiment group to carry out partial stimulation test,acute toxicity test and long - term toxicity test. Nebula dilution was sprayed into the animals＇ nasal cavity in dilution control group and nothing was sprayed in blank group. All the animals were sacorficed after observation. The animals＇ nasa cavity, pharyngeal portion , laryngopharyngeal recess, and internal organ were fixed with 10% neutral formalin and sectioned before examination under light microscope. Results Evident toxic and pathological damages were not observed in experiment group and the other groups in partial stimulation test, acute toxicity test, and long - term toxicity test. Conclusions rhlFNα - 2b nebula is not evidently harmful to guinea pig＇ s and rabbit＇ s nasal cavity mucosa and internal organs, proving that rhIFNα -2b nebula is reliably safe.

关 键 词：rhIFNα-2b喷雾剂 毒性 病理学 

分 类 号：R361[医药卫生—病理学]