重组人白蛋白干扰素α-2b融合蛋白的稳定性研究

The stability study of recombinant human serum albumin-interferon-α-2b fusion protein

研究重组人白蛋白干扰素α-2b融合蛋白(rHSA-IFNα-2b)的稳定性。以抗病毒活性和纯度为主要检测指标,考察rHSA-IFNα-2b的热稳定性,酸碱稳定性以及冻融耐受性。rHSA-IFNα-2b在37℃、55℃下放置5h后生物学活性无明显降低,60℃水浴1h即可见活性降低了约40%;pH值(分别为2、3、9)改变时,生物学活性未发生明显变化;rHSA-IFNα-2b反复冻融后聚合体逐渐增加,冻融4次后聚合体含量达到17.91%,但生物学活性无明显降低。重组人白蛋白干扰素α-2b融合蛋白对热、酸碱变化稳定,但不宜冻融。

The research was developed to evaluate the stability of recombinant human albumin interferon fusion protein （ rHSA-IFNα-2b）. Anti-viral activity and purity were used as the main indexes to evaluate the thermal stability, acid-base stability and freeze thawing tolerance. The bioactivity of rHSA-IFNα-2b did not decrease significantly at 37℃ and 55℃ for 5 hours, but decreased by 40% at 60 ℃ for 1 hour. The bioactivity showed no significant change after being stored at pH 2 and pH 9 for 12 hours or frzen thawing four times. The dimer increased gradually after freezing thawing four times, and the concentration of dimer reached 17. 91%. Our results demonstrated that rHSA-IFNα-2b is stable at different temperature and pH values, but it is not suitable for freeze thawing.