CAJ | 학술논문

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106IU／mg蛋白，相对分子质量为63057，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。
목적　연구화학정신형장효간우소제품질량공제방법。방법 채용Wish세포-VSV병독계통측정간우소적생물활성，채용기질보조격광해흡부비행시간질보법측정상대분자질량，채용모세관등전취초법측정양품적등전점，응용이단백매소화법측정태도。결과 학정료장효간우소제품적질공방법，응용해방법측정3비장효간우소비활성위106IU／mg단백，상대분자질량위63057，등전점위5.6。결론 건립적질공방법가이유효지공제장효간우소적제품질량。
Objective To establish the quality control methods for the chemical modified interferonproduct. Methods Bioactivity was assayed by Wish-VSV system. Molecular weight was determined by matrix-asisted laser desorpfion ionization time-of-flight mass spectrometry(MALDI-TOF-MS). Isoelectric point wasmeasured by high performance capillary isoelectrie focusing. Pepfide map was determined after trypsin treat-ment. Results The quality control methods were established and used for detecting 3 lots of chemical modifiedinterferon. The specific activity,molecular weight and pI of the 3 lots were 106IU／mg protein,63057 and 5.6respectively. Condusion The methods can be used for the quality control of chemical modified interferonproduct.