Processing And Detection Method Research Of Recombinant Human Granulocyte Colony Stimulating Factor Injection

Recombinant human granulocyte colony stimulating factor is mainly used for anti-tumor treatment of neutropenia.In this paper the technological process of rh G-CSF are studied,through the expression containing human granulocyte colony stimulating factor(G-CSF)gene of e.coli,obtain rh G-CSF inclusions,after fermentation,separation and highly purified made into injection.This paper studies the rh G-CSF examination method,the appearance,identification,visible foreign matter,quantity,p H value,osmotic pressure,residual antibiotic activity,sterile,endotoxin,protein content,abnormal toxicity,and other indicators of rh G-CSF the study of detection method,conform to the requirements.In addition,this article also to rh G-CSF protein content determination methodology of verification,through quantitative limit,accuracy,precision,specificity,linearity and range,solution stability,durability aspects of rh G-CSF protein content detection method for validation and verification,the results are accord with a standard,proved that described in this article the test method is suitable for the rh G-CSF protein content detection.