重组人干扰素α-2a口含片剂的豚鼠毒性试验  

Toxicity Test of Recombinant Interferonα-2a Buccal Tablets in Guinea Pigs

作　　者：李芳 赵晓青[2] 姜志恒[3] 赵亚力[2] 周捷[2] 许彦国 程晓耕[2] 

机构地区：[1]辽宁武警总队大连医院,辽宁大连116013 [2]长春生物制品研究所,吉林长春130062 [3]吉林大学药学院,吉林长春130021

出　　处：《临床军医杂志》2007年第6期837-838,共2页Clinical Journal of Medical Officers

摘　　要：目的评价重组人干扰素α-2a（rIFNα-2a）口含片剂对豚鼠口腔黏膜及内脏器官的毒性作用。方法设试验组、赋形剂组及空白对照组,每组用6只豚鼠,试验组口含rIFNα-2a片剂（300 IU/片）,1片/d,含5～7min,连续含服6 d。赋形剂组口含乳糖颗粒片剂（0.15 g/片）,方法同上。空白对照组未含任何物质。临床观察6 d后全部活杀。剖检口腔黏膜、咽部黏膜及内脏等器官,10%甲醇液固定,常规病理制片,HE染色,光镜观察。结果试验组与赋形剂组和空白对照组之间的组织病理学所见相似,均未见明显毒性病理损伤。结论rIFNα-2a口含片剂对豚鼠口腔黏膜及内脏器官均未见明显毒性作用,证实rIFNα-2a口含片剂安全可靠。Objective To evaluate the toxicity of recombinant interferonα-2a（rIFNα-2a） buccal tablets to the oral mucosae and internal organs of guinea pigs.Methods Eighteen guinea pigs were divided into trial group,parallel control group and blank control group（n=6/group）.The animals in the trial group were given rIFNα-2a buccal tablets（300 IU/tablet） and those in the parallel control group given lactose tablets（0.15 g/tablet） once a day for six days.The animals in the blank control group were given no tablets.All the guinea pigs were killed,and then the oropharyngeal mucosae were taken out as well as the internal organs.The specimens were fixed with 10% formalin and prepared into pathological slices which were stained by HE staining and observed by optical microscopy.Results No significant histopathological changes were observed in the mucosae or the organs of the animals in the three groups.Conclusion It is indicated that rIFNα-2a buccal tablets show no significant toxicity to oral mucosa and internal organs of guinea pigs and prove safe.

关 键 词：rIFN-α2a 口含片 豚鼠 毒性试验 

分 类 号：R967[医药卫生—药理学]