重组人干扰素α-2b滴鼻剂的研制

Study and preparation of recombiant human interferon-α2b naristilla

重组人干扰素α-2b(rIFNα-2b)滴鼻剂的试制及临床前工作研究。进行了理化和生物学性质试验、稳定性试验、鼻腔局部刺激性试验、急性毒性试验、长期毒性试验和动物体内抗病毒试验等。本品连续三批工艺稳定,检定合格,性质稳定,2～8℃保存24个月后生物学活性无明显下降,使用安全,无不良反应。其它各项试验均符合现行《中国药典》的要求。表明该制剂具有比较好的开发与应用前景。

To prepare rIFNα2b naristilla and provide a basis for clinic, we detected its physicochemical and biological properties, stability test, nasal irritation test, acute toxicity test and long toxicity test. The rIFNα2b naristilla showed good anti-virus activity and safety and good stability of biological characteristics. The rIFNα2b naristilla may possess a promising prospect of development and application.