注射用重组人干扰素α_(2b)冻干制剂稳定性试验

Studies on the stability of recombinant human interferon-α_(2b) injection

本文通过对三批注射用重组人干扰素α2b(rIFN -α2b)冻干制剂在不同温度下 ,保存不同时间取样 ,对其外观、生物学活性、pH值、溶解状态及无菌试验等各项理化指标的观察试验 ,结果本品的冻干制剂在 -2 0℃和 4— 8℃的条件下保存 4 2个月 ,其上述各项检定指标无明显变化 ,均符合质检规程 ,即本制品在此条件下稳定性良好 ,有效期可定为三年。同时说明该产品的生产工艺稳定。

The studies on appearance、sterile test、pH、solvability and bioactivity of rIFN-α 2b injection.The results showed that its bioactivity still remained after storage at 4-8℃ and -20℃ for 42 monthes and the other characters were not variable.