考察尿素含量对重组人粒细胞刺激因子质量的影响  

Preliminary study on the influence of urea content on recombinant human granulocyte colony-stimulating factor quality

作　　者：严君喜[1] 葛永红 杜林方[1] 

机构地区：[1]四川大学生命科学学院,四川成都610064 [2]成都生物制品研究所,四川成都610023

出　　处：《中国生化药物杂志》2006年第5期270-272,共3页Chinese Journal of Biochemical Pharmaceutics

摘　　要：目的考察尿素含量对重组人粒细胞刺激因子(rhG-CSF)质量的影响。方法将含量分别为98%,99.5%的尿素用于rhG-CSF的变复性工艺,并对制成的原液、半成品和成品,按照2005年版《中国药典》分别进行各项质量检测。结果用含量为98%和99.5%的尿素原材料所生产的3批产品的原液和成品,均符合2005年版《中国药典》rhG-CSF注射液的各项要求。结论尿素原材料中尿素含量只要达到≥98.0%的标准就可用于生产,不仅工艺稳定,而且还能降低成本。Purpose To study the influence of urea content on recombinant human granulocyte colony-stimulating factor（rhG-CSF） quality. Methods The rhG-CSF inclusion bodies expressed in the E. coli were washed using 2 mol/L urea and dissolved in 6 mol/L guanidine/HCl. The rhG-CSF were purified with high purity （ 〉 95 % ） through chromatography. All tests were all fulfilled accordingly to the National Requirments for Biological Products. Results The results of all three simultaneous batches of bulk, final bulk and final product tests complied with the requirements of quality control of rhG-CSF. Conclusion Urea will meet the demands of the industrial production if urea content is over 98 %. The cost was much lower.

关 键 词：尿素含量 重组人粒细胞刺激因子 复性 纯化 质量 

分 类 号：R927.2[医药卫生—药学]