重组人红细胞生成素新制剂及其稳定性研究  

New Preparation of Recombinant Human Erythropoietin and Study of Its Stability

作　　者：侯绪凤 侯剑英[1] 唐其凤 

机构地区：[1]沈阳三生制药股份有限公司,辽宁沈阳110027

出　　处：《微生物学杂志》2003年第1期15-18,共4页Journal of Microbiology

摘　　要：确定一种新的重组人红细胞生成素 (rHuEPO)保护剂 ,避免使用人血白蛋白 (HumanAlbumin ,HSA)造成一些潜在的血源性污染问题。设立对照组和实验组 ,对照组以HSA作保护剂 ,实验组为rHuEPO溶液中加入不同浓度的Tween80和L 组氨酸盐酸盐 ,分别存放不同时间 ,不同温度和湿度条件下测定rHuEPO的体内活性。通过对实验数据进行统计学处理 ,分析 2组配方是否存在差异。在P =0 .0 5水平 ,Tween80浓度在 0 .0 8‰以上 ;L 组氨酸盐酸盐浓度在 1‰以上实验组与对照组无显著差异。说明Tween80和L 组氨酸盐酸盐可以代替HSA作为rHuE PO的保护剂。Objective To prepare a new stabilizer for recombinant human erythropoietin (rHuEPO) to avoid potential contamination of human serum albumin(HSA). Methods The rHuEPO solutions are formulated by adding Tween80 and L-histidine hydrochloride with different concentration, and then stored for different duration at different temperature and humidity. The in vivo bioactivities of the rHuEPO solutions are measured and compared with that of the control containing HSA as the stabilizer. According to the result of statistical analysis, the discrepancy is observed between the test solution and control. Results When the concentration of Tween80 and L-histidine hydrochloride is more than 0.08‰ and 1‰ respectively, the bioactivities of the rHuEPO in the test group and control group have not significant discrepancy(p>0.05). Conclusion The Tween80 and L-histidine hydrochloride can be used as the substitute of HSA as the stabilizer in the rHuEPO formulation.;

关 键 词：RHUEPO 稳定性Tween80 L-组氨酸盐酸盐 

分 类 号：R944.11[医药卫生—药剂学]