摘要
目的通过对注射用重组人血清白蛋白-干扰素α2b融合蛋白的生物学活性检测方法进行研究,建立该药物的生物学活性检测方法。方法参考重组人干扰素生物学活性测定法,以人羊膜细胞(WISH)病变抑制法开展注射用重组人血清白蛋白-干扰素α2b融合蛋白的生物学活性检测方法研究。结果该方法的专属性好,精密度试验中生物学活性相对标准偏差(RSD)为10.6%,准确性试验平均回收率98.2%,RSD为9.0%,符合生物制品质量检验方法要求。结论本研究制定的实验方法准确、可靠,适用于注射用重组人血清白蛋白-干扰素α2b融合蛋白的生物学活性检测。
Objective To establish methods for bioactivity detection of recombinant human serum albumin-interferon α2b fusion protein for injection .Methods Bioactivity was assayed by WISH-VSV system ,taking meth-ods for bioactivity detection of recombinant human interferon as reference .Results The methods were specific . The RSD value in the precision test was 10.6% ,and the average recovery rate was 98.2% with RSD 9.0% .Con-clusion The established methods were specific and accurate ,which can be used to determine the bioactivity of re-combinant human serum albumin-interferonα2b fusion protein for injection .
出处
《山西医药杂志》
CAS
2014年第5期499-501,共3页
Shanxi Medical Journal
关键词
重组融合蛋白质类
血清白蛋白
生物学活性
方法学研究
干扰素α2b
Recombinant fusion proteins
Serum albumin
Interferon alfa-2b
Bioactivity
Study of the methods
