重组人干扰素α2b栓剂稳定性研究  

Stability of Recombinant Human Interferon α2b Suppository

作　　者：郝淑美[1] 郭桥[2] 王晓波[2] 肖艳玲[2] 郑辉[2] 鲁文艳[2] 韩俊海[2] 

机构地区：[1]长春理工大学,吉林长春130022 [2]长春生物制品研究所,吉林长春130062

出　　处：《微生物学杂志》2007年第1期85-87,共3页Journal of Microbiology

摘　　要：研究重组人干扰素α2b栓剂的稳定性。方法将重组人干扰素α2b栓在不同温度下保存不同时间，分别检验干扰素生物学活性、溶出度试验、融变时限、pH和微生物限度及外观的稳定性。结果重组人干扰素α2b栓在4～8℃条件下放置当时和放置48个月后的IFN生物学活性基本一致，未见下降；在20-25℃条件下放置24个月后IFN生物学活性未见下降，放置32个月后活性下降32％，36个月后IFN生物学活性下降55％；37℃条件下放置4个月后IFN生物学活性未见下降。结论重组人干扰素α2b栓剂的生物学活性及理化性质的稳定性好。The stability of recombinant human interferon α2b （rhIFN α2b） suppository was studied by storing it in different temperatures for different times, then the samples were taken and tested for physioehemieal property and bioaetivity. The results showed that its bioaetivity had no significant decrease after storing at 4-8 ℃ for 48 months, at 20-25 ℃ for 24 months, and at 37℃ for 4 months. However, its bioaetivity decreased by 32% and 55% after storing at 20-25 ℃ for 32 months and 36 months respectively. Its physioehemieal property showed no significant change after storing at different temperatures and different times. Therefore, it showed good stability.recombinant human interferon

关 键 词：重组人干扰素Α2B 栓剂 生物学活性 稳定性 

分 类 号：Q511[生物学—生物化学]