聚乙二醇化重组人白细胞介素-6生物学活性工作标准品的校准和稳定性研究  

Calibration and stability study on working standard in determination of biological activity of pegylated recombinant human interleukin-6

作　　者：邓杰[1] 张珂[1] 饶海林 王智杰[1] 赵兆[1] 曾海鹏[1] 李晓容[1] 周宇[1] 袁涛[1] 

机构地区：[1]成都生物制品研究所有限责任公司,成都610023

出　　处：《微生物学免疫学进展》2013年第2期24-27,共4页Progress In Microbiology and Immunology

基　　金：四川省科技厅科技攻关项目(05SG022-019)

摘　　要：目的对聚乙二醇化重组人白细胞介素-6生物学活性工作标准品进行校准和稳定性研究。方法按《中国药典》三部(2010版)的要求,检测工作标准品的生物学活性,以IL-6国际标准品进行校准,并研究其在不同温度下放置的稳定性。结果聚乙二醇化重组人白细胞介素-6工作标准品经8次试验,每次分别在3个96孔板上检测生物学活性,并以国际标准品进行校准,共获得24个校准活性结果。平均生物学活性的95%可信区间为2.0×106～3.8×106AU/mL,单次测定范围为1.9×106～3.8×106AU/mL,平均可信限率为3.771%。工作标准品分别在-20℃、4℃、25℃、37℃条件下放置12个月,其生物学活性保持稳定。结论所制备的工作标准品可用于聚乙二醇化重组人白细胞介素-6中试工艺的研究和每批产品质量的评价。Objective The working standard for pegylated recombinant human interleukin-6 in determination of its biologi-cal activity was caliberated and its stability was studied. Methods According to requirements in Chinese Pharmacopoeia （2010 edition）, it was carried out in determination of biological activity of pegylated recombinant human interleukin-6 by the working standard and calibration the standard by using of the international standard for IL-6, and stability test was car-ried out at different temperatures. Results The working standard was performed for 8 times in three 96 well plates, re- spectively and calibrated with the international standard, the 95% confidence interval for the average biological activity is 2.0xl06 to 3.8xl06AU/mL, a single measurement range is 1.9x106 to 3.8xl06AU/mL, the average credible line rate is 3. 771%. The working standard was stored at -20 ℃, 4 ℃, 25 ℃, 37 ℃ for 12 months, respectively, the biological ac-tivity was kept in stable. Conclusion The working standard could be used in researches on the pilot scale for pegylated re-combinant human interleukin-6 and evaluation of the quality of products in each batch.

关 键 词：聚乙二醇化重组人白细胞介素-6 生物学活性 工作标准品 稳定性 

分 类 号：R392[医药卫生—免疫学]