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目的 研究和确定新型长效干扰素制品质量控制方法。方法 采用Wish细胞 VSV病毒系统测定干扰素的生物活性 ,采用基质辅助激光解吸附飞行时间质谱法测定相对分子质量 ,采用毛细管等电聚焦法测定样品的等电点 ,应用胰蛋白酶消化法测定肽图。结果 确定了长效干扰素制品的质控方法 ,应用该方法测定 3批长效干扰素比活性为 10 6IU/mg蛋白 ,相对分子质量为 6 30 5 7,等电点为 5 .6。结论 建立的质控方法可以有效地控制长效干扰素的制品质量。
Objective To study and determine the quality control method of new long-acting interferon products. Methods The biological activity of interferon was determined by the method of Wish cell VSV virus system, and the relative molecular mass was determined by matrix-assisted laser desorption / ionization time of flight mass spectrometry. The isoelectric point of the sample was determined by capillary isoelectric focusing. The peptide map was determined by trypsin digestion . Results The quality control method of the long-acting interferon product was determined. The specific activity of the three long-acting interferon products was determined to be 10 6 IU / mg protein with a relative molecular mass of 6 30 5 7 and an isoelectric point of 5.6. Conclusion The established quality control method can effectively control the product quality of long-acting interferon.