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目的 :建立rht-PA效价测定用国家标准品。方法 :用UV法测定蛋白含量 ;HPSEC法分析纯度 ;体外凝块裂解气泡上升法测定效价 ;用t-PA国际标准品 (86 /6 70 )对国家标准品的效价进行标定。结果 :标准品的效价为每支 30 0 0 0IU ,RSD =3 34% (n =10 )。结论 :建立的rht -PA国家标准品可用于国内同类药物的研究开发和进口药品的质控
Objective: To establish a national standard for the determination of rht-PA titer. Methods: The protein content was determined by UV method; the purity was analyzed by HPSEC; the titer was determined by clot rising bubble method in vitro; the titer of national standards was calibrated by t-PA international standard (86/6 70). Results: The standard titer was 30,000 IU, RSD = 34 34% (n = 10). Conclusion: The established rht-PA national standards can be used for research and development of similar drugs in China and quality control of imported drugs