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目的 建立效价测定用的重组牛碱性成纤维细胞生长因子（ｈＦＧＦ）国家标准品。方法 按ＷＨＯ有 关要求制备标准品，分装、冻干后进行检定，以ｂＦＧＦ国际标准品为标准进行协作标定。结果 经检测外观、无菌实 验合格，水分为０．９９％，于－２０、４和２５℃条件下放置２３个月其生物活性稳定。该标准品经３家实验室协作标定， 共２３次测定，平均效价为６９７１支。实验均数的９５％可信区间为６２６６－７７５３ＩＵ／支，单次实验的９５％参考值范围 为３３９４－１０９６５ＩＵ／支，平均可信限率为 １０．９９５％。结抡 该批重组牛ｂＦＧＦ国家标准品各项指标均符合要求，可作 为国家标准品使用，效价定为７０００ＩＵ／支，批号为０１／９６。
Objective To establish a national standard for the determination of recombinant bovine basic fibroblast growth factor (hFGF) for potency determination. Methods According to the relevant requirements of the WHO to prepare standards, aliquots, freeze-dried after the test to bFGF international standards for collaborative calibration standard. The results of the test appearance, aseptic experiments pass, water was 0.99%, at -20,4 and 25 ℃ placed 23 months under the conditions of its biological activity is stable. The standard was calibrated by three laboratories, a total of 23 measurements, the average titer of 6,971. The 95% confidence interval of experimental mean was 6266-7753 IU / branch, the 95% reference range of single experiment was 3394-10965IU / branch, and the average confidence limit was 10.995%. Results of the batch of recombinant bovine bFGF national standard indicators are in line with the requirements, can be used as a national standard, titer set at 7000IU / support, batch number 01/96.