重组人干扰素α2b喷雾剂的研制

Preparation of Recombinant Human Interferon α2b Spray

目的重组人干扰素α2b(以下简称为rIFNα2b)喷雾剂的试制及临床前实验。方法将重组人干扰素α2b原液进行稀释,调整pH和渗透压,加入适宜稳定剂,除菌过滤后分装于带有定量喷雾装置的棕色玻璃瓶。对配制好的制品分别进行理化和生物学试验、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。结果连续3批制品经检定各项指标均合格,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。其他各项检定指标均符合现行《中国药典》的要求。结论研制的rIFNα2b喷雾剂安全、稳定,具有一定的抗病毒作用和潜在的临床应用价值。

Objective To prepare recombinant human interferon α2b spray.Methods Dilute the bulk of recombinant human interferon α2b,adjust pH and osmotic pressure,add a suitable preservative,sterilize by filtration and distribute into brown glass bottle with a device for quantitatively spraying.Perform physiochemical test on the prepared spray,biological test,stability test,local stimulation test in nasal cavity,acute toxicity test,long-term toxicity test and antiviral test in vivo.Results A total of 3 consecutive batches of recombinant human interferon α2b spray were qualified in control tests.The biological activity of spray showed no significant decrease after storage at 2-8℃ for 24 months.The spray was safe and induced no adverse reaction.The other quality indexes of the spray met the requirements in Chinese Pharmacopoeia.Conclusion The prepared recombinant human interferon α2b spray was safe,stable and showed a certain antiviral effect and potential value in clinic.