Calibrating the working standard for rhG-CSF
- VernacularTitle:重组人粒细胞集落刺激因子生物学活性工作标准品的标定
- Author:
Qian JIA
;
Xingjun ZHOU
;
Xuehong TIAN
;
Yuling FAN
;
Xiaobo QI
;
Zhihua ZHANG
- Publication Type:Journal Article
- From:
Chinese Journal of Biochemical Pharmaceutics
2001;22(2):81-84
- CountryChina
- Language:Chinese
-
Abstract:
Purpose Both the working standard and corresponding sample(GRAN75)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(GRAN75).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.
