摘要
目的研制出安全有效、稳定性好的重组人干扰素α2b凝胶。方法以重组人干扰素α2b为主药,卡波姆、明胶为凝胶基质,制备重组人干扰素α2b凝胶;通过扫描电镜(SEM)观察其微观结构;对生物学活性等主要质量指标进行稳定性考察;采用豚鼠进行皮肤过敏研究、采用新西兰兔进行皮肤刺激和局部刺激研究。结果制备的重组人干扰素α2b凝胶外观光滑透明、触感细腻,电镜扫描其微观结构呈三维网络状;干扰素生物学活性稳定,外观及pH等主要质量指标在18个月内稳定;重组人干扰素α2b凝胶给予豚鼠皮肤涂抹,未见皮肤过敏反应发生;新西兰兔破损皮肤重复涂抹给予重组人干扰素α2b凝胶后,未见与供试品相关的皮肤刺激性反应;新西兰兔完整皮肤和阴道重复给予重组人干扰素α2b凝胶后,皮肤给药和阴道给药未见与供试品相关的刺激性反应。结论研制的重组人干扰素α2b凝胶具有良好的稳定性,安全性,有广阔的临床应用前景。
OBJECTIVE To developed a safe,effective and stable recombinant human interferonα2b gel.METHODS Recombinant human interferonα2b gel was prepared by using recombinant human interferonα2b as the main drug,carbomer and gelatin as gel matrix.The microstructure of interferonα2b gel was characterized by using scanning electron microscope.Investigate major quality indicators such as biological activity.Skin allergy studies were performed using guinea pigs,skin irritation and local irritation studies were performed using New Zealand rabbits.RESULTS The prepared recombinant human interferonα2b gel was smooth and transparent in outward appearance,delicate in touch;The microstructure of the gel was three-dimensional network.The biological activity of interferon was stable and the main quality indexes such as appearance and pH were stable within 18 months.No skin allergic reaction occurred in guinea pigs by skin application of recombinant human interferonα2b gel.The skin irritation reaction associated with the test article was not observed after repeated application of the damaged rabbit skin and intact skin to the recombinant human interferonα2b gel.There was no irritating response associated with the test article after repeated administration of recombinant human interferonα2b gel to New Zealand rabbit vaginal.CONCLUSION The recombinant human interferonα2b gel has good stability,safety and broad clinical application prospects.
作者
倪晓燕
周乐春
储成风
王荣海
宋礼华
NI Xiao-yan;ZHOU Le-chun;CHU Cheng-feng;WANG Rong-hai;SONG Li-hua(Anhui Anke Biotechnology(Group)Co,Ltd.,Hefei 230088,China;Anhui Biological Institute,Hefei 230088,China)
出处
《海峡药学》
2020年第3期8-11,共4页
Strait Pharmaceutical Journal
基金
国家“重大新药创制”科技重大专项(2008ZX09203-003)国家“重大新药创制”科技重大专项(2011ZX09202-301-02)。
关键词
重组人干扰素Α2B
凝胶
安全性
Recombinant human interferonα2b
Gel
Safety evaluation
作者简介
倪晓燕。学历:医学硕士。职称:助理研究员。主要从事生物药制剂开发与药物临床前研究工作。E-mail:xiaoyan_nini@163.com;通讯作者:宋礼华。职称:研究员,博士生导师。基因工程药物研究方向。E-mail:songlh@ankebio.com。
