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目的:通过比较不同温度对静注人免疫球蛋白(IVIG)质量的影响,为该类制品的运输和储存温度控制提供科学依据。方法:设置不同的考核温度,采用高效液相色谱法、聚丙烯酰胺凝胶电泳法和该品种药典规定的部分检测项目和方法进行分析。结果:37℃孵放7d或45℃以上温度孵放1d,免疫球蛋白将形成聚合体和裂解片断;高温(60℃以上)使免疫球蛋白快速聚合,形成大量二聚体或高分子聚合体。聚合体形成后使生物学活性及部分理化性质明显降低和改变。结论:静注人免疫球蛋白应严格执行4℃冷藏保存条件,运输时间超过24h必须使用冷藏车进行冷链运输。
OBJECTIVE: To provide a scientific basis for controlling the transport and storage temperature of such products by comparing the effects of different temperatures on the quality of intravenous immunoglobulin (IVIG). Methods: Set different assessment temperature, using high performance liquid chromatography, polyacrylamide gel electrophoresis and the varieties of Pharmacopoeia part of the test items and methods for analysis. Results: The immunoglobulin would form aggregates and lysis fragments after incubating at 37 ℃ for 7 days or over 45 ℃ for 1 day. High temperature (above 60 ℃) allowed the immunoglobulins to polymerize rapidly to form a large amount of dimer or polymer . After the formation of the polymer biological activity and some of the physical and chemical properties significantly reduced and changed. Conclusion: The intravenous immunoglobulin should be strictly enforced at 4 ℃ refrigerated storage conditions, transport time more than 24h must be refrigerated trucks cold chain transport.