摘要
目的 考察重组人干扰素α2b注射液的稳定性.方法 按照＆lt;中国药典＆gt;2010年三部的方法进行检测,其中干扰素蛋白纯度采用高效液相法测定,光照试验、振摇试验、冻融试验、加速试验、低温长期留样观察方法均采用药典方法.结果 除了冻融试验中反复冻融8次后和加速试验中（37±2）℃放置3个月,干扰素α2b效价下降至理论值的80%以下,其余试验抽样点均符合质量标准的规定.结论 该品在避光,2~8 ℃密闭的储存条件下性质稳定,贮存期可为2年左右.
Objective To study the stability of recombinant hmnan interferon α2b injection. Methods According to the methods of Ch. P for testing, tile protein purity of interferon were determined by HPLC. The stability of the samples were tested by strong-light, shaking, freeze thaw, accelerating experiment and prdonged low-temperuture storage. Results After being exposured to repeated freezing and thawing 8 times and accelerating test for 3 months in 37 ℃, interferon potency was reduced to less than 80% of the theo- retical value, but on other experiments,it was rather stable. Conclusion This injection should be kept away from high light and may be stored for 2 years at 2 - 8 ℃.
出处
《安徽医药》
CAS
2014年第3期433-436,共4页
Anhui Medical and Pharmaceutical Journal
基金
国家"重大新药创制"科技重大专项(No 2011ZX09202-301-02)
