重组人干扰素α1b滴眼液稳定性的研究  

Study on stability of recombinant human interferon α 1b in eye drop form

作　　者：郑辉[1] 崔颖杰[1] 郭桥[1] 鲁文彦[1] 王晓波[1] 李文波[1] 朱丽娜[1] 

机构地区：[1]吉林长春生物制品研究所基因药物室,长春130060

出　　处：《生物学杂志》2005年第5期31-32,30,共3页Journal of Biology

基　　金：长春生物制品研究所研究开发中心资助

摘　　要：重组人干扰素α 1b滴眼液放置不同温度和不同时间后,定期测定其效价、无菌试验、pH值和外观,在4℃条件下,24个月内pH、无菌试验、外观和0月一致,没有明显变化;生物学活性24个月没有降低;室温(18～25℃)放置12个月活性明显降低,pH、无菌试验、外观和0月一致;37℃放置6个月活性基本丧失,pH、无菌试验、外观和0月一致.重组人干扰素α1b滴眼液在4℃条件下生物活性及其他理化性质稳定性较好.The stability of recombinant human interferon a lb（rhlFN a lb）eye drops was studied, rhlFN a lb eye drops were stored at different temperatures for different time and taken the tests for potency, sterility, pH and appearance. The pH, sterility and appearance of rhlFN a 1 b eye drops showed no significant changes after storage at 4 ~C for 24 months, and at room temperature （ 18 - 25~C ） for 12 months or at 37℃ for 6 months .The bioactivity of the product showed no significant change after storage at 4℃ for 24 months, but decreased significantly at room temperature for 12 months and almost lost at 37℃ for 6 months. The result showed that with proper storage rhlFN α 1 b eye drops had good stability.

关 键 词：重组人干扰素 滴眼液 稳定性 

分 类 号：R392-33[医药卫生—免疫学]