摘要
采用毛细管电泳、反相HPLC、凝胶排阻HPLC、SDS-PAGE非还原电泳、pH值、生物学活性等检测方法对重组人粒细胞集落刺激因子注射液的稳定性进行系统研究,在加速试验、室温留样、贮藏温度留样条件下检测了稳定性。结果样品于2～10°C保存下,外观、pH值、含量、纯度及生物学活性均相当稳定,有效期可暂定为两年。
The stability of the recombinant human granulocyte colony stimulating factor injections under accelerated test condition,room temperature,storage temperature and other affecting factors was determined by capillary zone electrophoresis, RP HPLC, high performance size exclusion chromatography, SDS PAGE, pH determination and biology activity.The results showed that these injections were stable to all tests and the shelf life could be tentatively fixed at two years.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2000年第3期123-124,共2页
Chinese Journal of Pharmaceuticals
关键词
注射液
稳定性
加速试验
RHG-CSF
recombinant human granulocyte colony stimulating factor
injections
stability
accelerated test
