重组人干扰素α 2b栓剂稳定性研究

Stability of recombinant human interferon α 2b suppository

将重组人干扰素α2b栓剂在不同温度下保存不同时间，检验干扰素生物活性、溶出度试验、融变时限、pH值和微生物限度及外观的稳定性。重组人干扰素α2b栓剂在4～8℃条件下放置48个月；在20～25℃条件下放置24个月IFN生物活性未见下降，37℃放置4个月IFN生物活性未见下降。重组人干扰素α2b栓剂的生物学活性及理化性质有较好的稳定性。

To study the stability of recombinant human interfer on α2b（ rhIFN α2b）suppository ,rhIFN α2b suppository was stored at different temperature for different time. The samples of physicochemical property and bio-activity were assayed. The bioactivity of rhIFN α2b suppository showed no significant decrease after storage at 4～8℃ for 4 years,at 20～25℃ for 2 years or at 37℃ for 4 months. The physiochemical property of rhIFN α2b sup-pository showed no significant change after storage at different temperatures for different time. Result showed that the rhIFN α2b suppository had good stability at room temperatcme.