聚乙二醇化重组人白细胞介素-6工作标准品的制备  

Preparation of working standard for PEG-recombinant human interleukin-6

作　　者：袁涛[1] 张珂[1] 李征[1] 王智杰[1] 邓杰[1] 周宇[1] 赵兆[1] 饶海林 张雪梅[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：《中国生物制品学杂志》2012年第1期50-55,共6页Chinese Journal of Biologicals

基　　金：四川省科技厅科技攻关项目(05SG022-019)

摘　　要：目的制备重组人白细胞介素-6(Recombinant human interleukin-6,rhIL-6)和聚乙二醇化rhIL-6(PEG-rhIL-6)理化工作对照品和rhIL-6冻干体外生物学活性工作标准品,用于PEG-rhIL-6制备过程中各步样品纯度、理化指标及体外生物学活性测定。方法制备rhIL-6和PEG-rhIL-6,并对其进行全面检定,作为理化工作对照品。另取精确定量的rhIL-6,用含冻干保护剂的缓冲液稀释分装冻干,制成冻干制品后对其进行全面检定及稳定性考察,作为体外冻干生物学活性工作标准品。结果两种理化工作对照品和冻干体外生物学活性工作标准品各项常规检测指标均符合暂定规程要求;两种理化工作对照品结构分析结果证实与理论值相符;冻干体外生物学活性工作标准品加速稳定性试验证明其体外活性稳定。结论制备的两种理化工作对照品和冻干体外生物学活性工作标准品可用于PEG-rhIL-6中试工艺的研究和评价。Objective To prepare the working references for physico-chemical determination of recombinant human interleukin-6 （rhIL-6） and PEG-rhIL-6 as well as working standard for bioactivity determination of freeze-dried rhIL-6, and apply to determination of purity, physic-chemical indexes and in vitro bioactivity of PEG-rhIL-6 during preparation. Methods Both rhIL-6 and PEG-rhIL-6 were prepared, subjected to overall control tests and served as working references for physico-chemical determination. Precisely measured rhIL-6 was diluted with buffer containing stabilizer, then filled, lyophilized, subjected to overall control tests, evaluated for stability and served as freeze-dried working standard for in vitro bioactivity determination. Results All the routine quality indexes of the working references and working standard met the requirements in temporary regulations. The structural analysis results of working references were consistent with the theoretical values. Accelerated stability test showed high in vitro activity of freeze-dried working standard. Conclusion The prepared working references for physico-chemical determination and freeze-dried working standard for in vitro bioactivity determination may be used for the research and evaluation on pilot process of PEG-rhIL-6.

关 键 词：聚乙二醇化 白细胞介素6 理化对照品 体外生物学活性测定 工作标准品 

分 类 号：R392-33[医药卫生—免疫学]