【摘要】 目的：研究用ＴＦ－１细胞测定ｒｈＧＭ－ＣＳＦ（重组人粒／巨噬细胞集落刺激因子）生物学活性的方法并用ＷＨＯ ｒｈＧＭ－ＣＳＦ国际标准品进行工作标准品和对照品（生白能先灵产品）的联合标定。方法：采用 ＭＴＴ染色法。结果：首次将（４，４）法引入ｒｈＧＭ－ＣＳＦ生物活性的测定，使所标定的工作标准品生物效价为每瓶１．３７×１０６ ＩＵ，所标定的对照品生物效价为每瓶１．７９×１０６ＩＵ，效价的平均可信限率分别为 ４． ９０４％和 ４． ３３３％。结论：（４， ４）法可用于ｒｈＧＭ－ＣＳＦ生物活性的测定，结果便于统计分析。所标定的工作标准品可作为ｒｈＧＭ－ＣＳＦ生物活性测定的工作标准。更多还原

【Abstract】 OBJECTIVE: The method of measurement of rhGM-CSF biological activity by TF-1 cells was studied, and both the working standard and corresponding sample (Leuco- maxnR) were calibrated by WHO Iinternational standard for GM-CSF. METHODS: Mtt method. RESULTS: (4, 4 ) method was first adopted in the measurement of rhGM-CSF biolodcal activity. The biological potency and the FL% of average potency are 1.37×106 IU/ampoule and 4.904 % for working standard, and 1.79×106 IU/ampoule and 4.333% for corresponding sample, resistively. CONCLUSION: (4, 4) method can be used in the measurement of rhGM-CSF biological activity, which make the measurement results very convenient for statistical analysis. The working standard which calibrated can be used as working standard.更多还原