Study On Preparation Of Decitabine For Injection

Decitabine,4-amino-1-(2-deoxy-β-D-erythro-pentofuranosyl)-1,3,5-Triazin-2(1H)-one,is an unique cytosine analog that inhibits DNA methyltransferases,reverses methylation and can reactivate silenced genes.It can induce tumor cell differentiate to normal cell or apoptosis in tumor cell.Decitabine is one of the two demethylation drugs that FDA has approvedDecitabine for injection can be prepared by freeze-drying.Dissolution of the drug,method of remove the bacterial endotoxin,control of the freeze-drying process have been studied.Process of preparing decitabine freeze-drying powder has been built.HPLC methods have been found to detect decitabine and the related substances.Related substances and transformations between them have been studied.Stability of the drug has been studied.Decitabine for injection has been prepared by freeze-drying.The decitabine freeze-drying powder has showed a good stabilization in the experiments.