新型重组人促红素注射液的研究与开发

本文介绍了一种新型重组人促红素注射液,其不含人血白蛋白,使用磷酸盐缓冲液作为缓冲体系,避免了对患者病毒感染及人血白蛋白过敏的危险,减轻了皮下注射时给病人造成的局部疼痛感觉,使药品更加安全.通过与市售的重组人促红素注射液进行药物动力学研究比较及对其进行稳定性考察,结果显示新型重组人促红素注射液更加安全有效、质量稳定.

Research and development of a new Recombinant Human Erythropoietin Injection

A new Recombinant Human Erythropoietin Injection is introduced. The patients would avoid virus infection and hypersusceptibility of Human Albumin,and would feel less pain in hypodermic injection location when using the new injec- tion that containing Phosphate Buffer and without Human Albumin. This injection is same efficacious and stable compared with commercial injection that containing Human Albumin. Comparing with commercial injection that containing Human Albumin by kinetics and stability study,we affirm the new injection is more safe-effective and stable.