CAJ | 학술논문

目的用世界卫生组织(WHO)粒细胞集落刺激因子(G-CSF)生物学活性国际标准品对所制备的重组人粒细胞集落刺激因子(rhG-CSF)生物学活性工作标准品以及惠尔血针剂-75进行标定。方法用NFS-60细胞采用MTT法进行rhG-CSF生物学活性的测定，(4，4)法计算测定结果。结果制备rhG-CSF生物学活性工作标准品3批，两批为冻干剂，与G-CSF生物学活性国际标准品配方一致，一批为水剂，与惠尔血针剂-75配方一致；用G-CSF生物学活性国际标准品对其标定，结果依次为3.062×106、4.276×106 IU/支及1.635×107 IU/ml，样品为1.880×107 IU/ml。标定结果的FL%分别为5.529%、4.291%、4.244%及5.175%。结论所标定的rhG-CSF生物学活性工作标准品可用于rhG-CSF生物学活性测定。
목적용세계위생조직(WHO)립세포집락자격인자(G-CSF)생물학활성국제표준품대소제비적중조인립세포집락자격인자(rhG-CSF)생물학활성공작표준품이급혜이혈침제-75진행표정。방법용NFS-60세포채용MTT법진행rhG-CSF생물학활성적측정，(4，4)법계산측정결과。결과제비rhG-CSF생물학활성공작표준품3비，량비위동간제，여G-CSF생물학활성국제표준품배방일치，일비위수제，여혜이혈침제-75배방일치；용G-CSF생물학활성국제표준품대기표정，결과의차위3.062×106、4.276×106 IU/지급1.635×107 IU/ml，양품위1.880×107 IU/ml。표정결과적FL%분별위5.529%、4.291%、4.244%급5.175%。결론소표정적rhG-CSF생물학활성공작표준품가용우rhG-CSF생물학활성측정。
Purpose　Both the working standard and corresponding sample(GRAN75)were first calibrated by WHO international standard for G-CSF.Methods　MTT method by NFS-60 cells was used. The results were calculated by (4,4)method.Results　Three batchs working standards were prepared,two batchs were freeze-dry and the prescription was same as WHO international standard for G-CSF,one batch was injection and the prescription was same as corresponding sample(GRAN75).The biological potency and the FL% of average potency were 3.062×106 、4.276×106IU/ampoule、1.635×107IU/ml and 5.529%、4.291%、4.244% for working standard, and 1.880×107IU/ml and 5.175% for corresponding sample,respectively.Conclusion　The working standard which calibrated could be used as working standard in the measurement of rhG-CSF biological activity.