注射用重组人干扰素α1b溶解后活性稳定性的分析  

Analysis of activity stability of recombinant human interferon α1b for injection after dissolution

作　　者：马鸿杰 刘传灵 黄秋茹 毛新 

机构地区：[1]深圳科兴生物工程有限公司,518057

出　　处：《中国实用医药》2017年第35期197-198,共2页China Practical Medicine

摘　　要：目的研究分析注射用重组人干扰素α1 b(赛若金)溶解后生物学活性的稳定性。方法按照《中国药典》2015年版干扰素活性检测第一法,采用细胞病变抑制法(CPE)检测溶解后的赛若金分别在4℃及25℃条件下放置不同时段的生物活性,与标准品比较,评估其溶解后的稳定性。结果 4批次不同规格的赛若金经4℃存放12、24、36、48 h后生物学活性相当于0 h活性的93.93%~100.31%,生物活性无明显的下降,相对稳定。4批次不同规格的赛若金经25℃存放12、24、36、48 h后生物学活性相当于0 h活性的81.90%~100.46%,生物活性有所波动,依旧在合格范围内。结论赛若金溶解后性质稳定,使用本品除了现配现用,还可以提前溶解配制,适当条件下保存使用。Objective To study and analyze the activity stability of recombinant human interferon α1 b for injection（Sinogen） after dissolution. Methods According to the first edition of Chinese Pharmacopoeia（2015 Edition） Interferon Activity Test, cytopathogenic effect（CPE） was used to detect the biological activity of Sinogen in different periods after being dissolved at 4 ℃ and 25 ℃ respectively, and they were compared with the standard, so as to assess its stability after dissolution. Results 4 batches of different specifications of Sinogen at 4 ℃ for 12, 24, 36, 48 h had biological activity equivalent to 93.93% ~ 100.31% at 0 h, no significant decrease in biological activity, and it is relatively stable. 4 batches of different specifications of Sinogen at 25 ℃ for 12, 24, 36, 48 h had biological activity equivalent to 81.90%~100.46% at 0 h, the biological activity fluctuates, but still in the qualified range. Conclusion After dissolution, Sinogen has stable properties, in addition to current use of this product, it can also be dissolved in advance, and stored under proper conditions.

关 键 词：注射用重组人干扰素 生物学活性 细胞病变抑制法 稳定性 

分 类 号：R91[医药卫生—药学]