【摘要】 本实验室构建了分泌型高效表达重组双功能水蛭素 (RGD-Hirudin) 的工程酵母，经发酵、纯化，获得重组双功能水蛭素纯品，其原液经质量分析，符合国家静脉注射用药的标准，可以用于制备静脉注射用粉针剂。

    【关键词】 注射用重组双功能水蛭素；质量研究

    Quality control of recombinant RGD-hirudin for injection

    ZHANG Yan-ling,MO Wei, WANG Long-sheng,et al.

    The Key Laboratory of Molecular Medicine, Ministry of Education, Fudan University，Shanghai 200032,China

    【Abstract】 The expression plasmid, HD-pPIC9K, was contructed by inserting cDNA of RGD-hirudfin (RGD-Hirudin) in yeast expression vector pPIC9K. This clone was fermented for 3 days，and the purified RGD-Hirudin was gained after purification. Quality analyses were tested. The RGD-Hirudin was measured up to standard of injection.

    【Key words】 RGD-hirudin for injection; quality control

    天然水蛭素是凝血酶的特异抑制剂，从医用水蛭的唾液腺中提取而得，可与凝血酶形成摩尔比为1:1的非共价相结合的可逆复合物，对凝血酶有很高的亲和力，使凝血酶失去裂解纤维蛋白原的能力，抑制纤维蛋白的形成，因此，低浓度的水蛭素可有效地抑制血液凝固[1] ......