注射用人组织尿激酶型纤溶酶原激活剂质量标准研究  

Study on the specification for quality control of human tissue urokinase plasminogen(HTUPA)

作　　者：丁有学[1] 韩春梅[1] 李响[1] 张翊[1] 饶春明[1] 王军志[1] 

机构地区：[1]中国药品生物制品检定所生化室,北京100050

出　　处：《药物分析杂志》2007年第6期787-790,共4页Chinese Journal of Pharmaceutical Analysis

基　　金：国家863高科技研究发展计划项目(2003AA2Z3480)

摘　　要：目的:建立注射用人组织尿激酶型纤溶酶原激活剂(HTUPA)的质控方法和质量标准。方法:以纤维蛋白平板法测定HTUPA 的生物学活性,还原型 SDS-PAGE 确定相对分子质量,SDS-PAGE 和反相高效液相色谱测定纯度,毛细管电泳法测定等电点,用胰蛋白酶酶切后分析肽图,其余检测项目按2005年版中国药典三部规定进行。结果:用建立的方法对原液和成品进行了检定,各项指标均符合《人用重组 DNA 制品质量控制技术指导原则》和2005年版中国药典三部的要求。结论:建立的质控方法和质量标准具有保证产品安全、有效、质量可控的特点,可用于注射用人组织尿激酶型纤溶酶原激活剂产品的常规检定。Objective：To establish methods and requirements for quality control of human tissue urokinase plasminogen（HTUPA）. Method： Bioactivity of HTUPA was determined by fibrin agar plate assay. Relative molecular mass of HTUPA was detected by reduced SDS - PAGE. Purity of HTUPA was analysed by SDS - PAGE and RP - HPLC. Isoelectic point and peptide mapping were detected by CE and tryptic digestion individually. Routine test were all analysed according to the Chinese pharmacopoiea. Results：The requirements and methods for quality control of HTUPA had been established and used for both HTUPA bulk and final product. The results of all test complied with Chinese pharmacopoiea and guidelines for quality control of recombinant DNA products. Conclusion：The methods and requirements for quality control of HTUPA can assure the products safety and efficiency, and have been used for routine quality control of HTUPA.

关 键 词：人组织尿激酶型纤溶酶原激活剂(HTUPA) 质量控制 生物学活性 

分 类 号：R917[医药卫生—药物分析学]