长效干扰素质控方法的研究

Quality Control Methods for Chemical Modified Interferon

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 establish the quality control methods for the chemical modified interferon product.Methods Bioactivity was assayed by Wish VSV system.Molecular weight was determined by matrix asisted laser desorption ionization time of flight mass spectrometry(MALDI TOF MS).Isoelectric point was measured by high performance capillary isoelectric focusing.Peptide map was determined after trypsin treatment.Results The quality control methods were established and used for detecting 3 lots of chemical modified interferon.The specific activity,molecular weight and pI of the 3 lots were 10 6 IU/mg protein,63057 and 5.6 respectively.Conclusion The methods can be used for the quality control of chemical modified interferon product.