首批重组人组织纤溶酶原激活剂国家标准品的研制

Establishment and Standardization of the National Reference Standard of Recombinant Human Tissue Plasminogen Activator

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

Objective:To establish a national reference standard for rht-PA potency.Methods:The protein content,the purity and the potency of rht-PA preparation were analyzed by UV,HPSEC and the clot lysis assay,respectively,using the Second International Standard for t-PA to calibrate national reference standard of rht-PA.Results:The first national reference standard for rht-PA was established,with an assigned potency of 30 000 international units(IU) each ampoule.Conclusion:The National reference standard for rht-PA has been established.It can be useful for the development of analogous drugs produced domestically and the quality control of import medicines.