2种测定TNK-tPA生物学活性测定方法的比对分析  

Comparative analysis to two biological activity detecting methods of TNK-tPA

作　　者：丁有学[1] 史新昌[1] 毕华[1] 陶磊[1] 饶春明[1] DING You-xue;SHI Xin-chang;BI Hua;TAO Lei;RAO Chun-ming(Key Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院卫生部生物技术产品检定方法及其标准化重点实验室,北京100050

出　　处：《药物分析杂志》2018年第12期2213-2217,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：科技重大专项"生物类似药物质量相似性评价体系建设研究(2015ZX09501008-001)"资助项目

摘　　要：目的:应用2种溶栓活性检测方法检测重组人组织型纤溶酶原激活剂TNK突变体(recombinant TNK mutant of human tissue-type plasminogen activator, TNK-tPA)生物学活性并统计分析两者结果是否一致。方法:采用纤维蛋白平板溶圈法和气泡上升法测定TNK-tPA生物学活性,并对结果进行统计分析。结果:纤维蛋白平板溶圈法测定结果几何均数为2.89×10~4 IU·支^(-1),气泡上升法测定结果几何均数为2.95×10~4 IU·支^(-1)。经t检验分析,2种方法检测结果无显著性差异(P>0.05)。经置换检验(permutation test)分析,2种方法检测结果数据相当(接受度概率约为90%)。结论:2种方法均可用于实验室的常规检验,但建议对于TNK-tPA的生物学活性检测使用气泡上升法。Objective:Two thrombolytic activity methods of recombinant human tissue type plasminogen activator mutant(TNK-tPA)were carried out and the results were analyzed to deduce if the results were similar. Methods: The biological activity of TNK-tPA was determined by dissolution-ring method and bubble-rising method,and the results were analyzed statistically. Results:The geometric mean of dissolution-ring method was 2.89×10^4 IUper vial and the geometric mean of bubble-rising method was 2.95×10^4 IUper vial. T test analysis showed that there was no significant difference between the two methods(P >0.05). According to permutation test,the data of the two methods were similar to each other(acceptance probability was about 90%). Conclusion:The both two methods can be used for routine laboratory tests.But the bubble-rising method was used for detecting the biological activity of TNK-tPA.

关 键 词：TNK-tPA 生物学活性 溶圈法 气泡上升法 置换检验 

分 类 号：R917[医药卫生—药物分析学]