Recombinant human erythropoietin (rhEPO) injection was clinically used in the treatment of renal anemia, perioperative red blood cell mobilization, tumor chemotherapy-induced anemia.Currently, domestic rhEPO,using human serum albumin as a stabilizer,can cause the body's own immune response in a certain extent. The experiments were had with 3 000 IU/mL EPO preparation as the inspection object. Firstly, the vitro activity residual ratio of rhEPO protein in the test formulation through the high temperature accelerated test was determined, the concentrations of the stabilizer including L-histidine hydrochloride and L-histidine hydrochloride. Secondly,some conditions were determined,which were based on the adding amount of the stabilizer with a suitable protecting agent Tween80 concentration of 0.006%, ratio of NaH2PO4 ·2H2O and Na2HPO4 ·12 H2O of 5/4, and the pH value of 6.10~6.30. Finally the new formulation of EPO preparation was selected.
白 燕,李岩异,张 颖. 重组人促红素注射液新工艺研究[J]. 煤炭与化工, 2013, 36(4): 38-40,43.
BAI Yan,LI Yan-yi,ZHANG Ying. Research on New Technology of rhEPO Injection. CCI, 2013, 36(4): 38-40,43.