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1.
Chinese Journal of Biochemical Pharmaceutics ; (6): 25-26, 2001.
Article Dans Chinois | WPRIM | ID: wpr-411958

Résumé

Purpose The determination method of rhG-CSF bio logical activity by NFS-60 cells was studied in accordance with WHO internation al standard for G-CSF.Methods MTT method was adopted.R esults The chomosone number of NFS-60 cell was 39, about 1×105 cells/ml to 1×107 cells/ml,the dying color showed gradient when the NFS-60 c ells was dyed by MTT,the method(4,4) was adopted in the determination of rhG-CS F biological activity,the average FL% of potency was 13.560% for single exprimen t,and the CV of inter-assay and intra-assay was lower than 10% and 10.109%,respectively.Conclusion method(4,4) can be us ed in the determination of rhG-CSF biological activity,and the results can guid e the study and the manufacture of rhG-CSF effectively.

2.
Chinese Journal of Biochemical Pharmaceutics ; (6): 81-84, 2001.
Article Dans Chinois | WPRIM | ID: wpr-411420

Résumé

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.

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