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在干扰素的研究中,由于测定方法不一,影响因素很多,给各实验室的理论研究和临床应用研究的结果的分析与比较带来了极大的困难。我们在人β干扰素(HuIFN-β)的研制过程中,也深感建立一种该类型的干扰素参考品的必要性。为满足本实验室研究工作及临床试用的需要,我们采用真空低温冷冻干燥的方法制备了一批人β干扰素参考品,现将其活性标化,无菌检查,以及热稳定性观察的结果报告如下。材料和方法粗制人β干扰素:采用新城鸡瘟病毒(NDV,B_1株)和人胚肌皮细胞(SM_2株)生产制备,经美国国立卫生研究院(NIH)提供的人α和β干扰素国际标准抗血清鉴定,其β
In the research of interferon, due to the different measurement methods and many influencing factors, it has brought great difficulties to the analysis and comparison of the theoretical research and clinical application research results of various laboratories. We are also deeply involved in the development of human interferon-beta (HuIFN-β), a necessity to establish an interferon reference of this type. In order to meet the needs of our laboratory work and clinical trial, we prepared a series of human interferon beta reference materials by using the method of vacuum cryogenic freeze-drying, and we now standardize their activity, sterility test, and the result of thermal stability observation The report is as follows. MATERIALS AND METHODS Crude human interferon beta (IFN-α): Human alpha and beta interferon produced by NDV (strain B_1) and human embryo myofibroblasts (SM_2) were prepared by the National Institutes of Health (NIH) International standard antiserum identification, the β