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目的 建立效价测定用重组链激酶国家标准品。方法 以NIBSC的国际标准品为标准 ,采用体外溶圈法 ,按WHO要求组织了 3家实验室 ,对该批rSK国家标准品 (批号 96 0 70 1)的效价进行协作标定。结果 经统计学分析 ,均数为 495IU/支 ,95 %可信区间为 45 7～ 5 35IU/支 ,单次测定的 95 %标准值范围为 30 1～ 70 6IU/支。该批国家标准品效价确定为 5 0 0IU/支。 4种不同温度存放 2 9个月的样品 ,效价稳定。结论 该批rSK效价稳定 ,可作为国家标准品。
Objective To establish a national standard for determination of recombinant streptokinase by titration. Methods Based on the international standards of NIBSC, three laboratories were set up according to WHO’s request by means of in vitro dissolution method and the potency of the batch of rSK national standards (batch number 96 0 70 1) was collaboratively calibrated. Results The statistical analysis showed that the mean was 495 IU per branch and the 95% confidence interval was 457-535 IU per branch. The 95% standard value for a single measurement ranged from 30 1 to 70 6 IU per branch. The batch of national standard price is determined as 500IU / support. Four different temperatures stored 29 months of samples, potency and stability. Conclusion This batch of rSK titer is stable and can be used as a national standard.