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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 in vitro biological activity of recombinant human interleukin-6 (rhIL-6) and pegylated rhIL-6 (rhIL-6) The standard product is used for the determination of the purity, the physical and chemical indexes and the in vitro biological activity of each step of the preparation process of the PEG-rhIL-6. Methods rhIL-6 and PEG-rhIL-6 were prepared and tested comprehensively as reference materials for physical and chemical work. Another precise amount of rhIL-6, diluted with lyoprotectant buffer diluted dispensing freeze-dried products made after a comprehensive test and stability study, as in vitro lyophilized biological activity standards . Results The results of two physical and chemical work standards and routine tests of lyophilized biological activity standards were in accordance with the requirements of the provisional regulations. The results of structural analysis of the two physical and chemical work standards were consistent with the theoretical values. The biological activity of lyophilized in vitro Accelerated stability of work standards test proved its in vitro activity and stability. Conclusions The prepared two kinds of physical and chemical work standards and lyophilized in vitro biological activity standards can be used for PEG-rhIL-6 pilot process research and evaluation.