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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 and pre-clinical experiments of recombinant human interferon α2b (hereinafter referred to as rIFNα2b) spray. Methods The recombinant human interferon α2b stock solution was diluted, the pH and osmotic pressure were adjusted, and the suitable stabilizer was added. After sterilization and filtration, it was dispensed in a brown glass bottle with a quantitative spray device. The preparation of good products were physical and chemical tests, stability tests, nasal irritation test, acute toxicity test, long-term toxicity test and animal anti-virus test. Results The three batches of products were tested successfully. All the indexes were qualified. No significant decrease in biological activity was observed after storage at 2 ~ 8 ℃ for 24 months. It was safe to use and had no adverse reactions. Other test indicators are in line with the current “Chinese Pharmacopoeia” requirements. Conclusion The developed rIFNα2b spray is safe and stable and has certain anti-virus effect and potential clinical application value.