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    • 10. 发明授权
    • Method for keeping the quality of aqueous parenteral solution of thrombomodulin in storage and distribution
    • 保持血栓调节素水溶液的质量的方法
    • US06808706B1
    • 2004-10-26
    • US09509994
    • 2000-05-08
    • Masaki YuiAkira YokozawaTomoyo MurataKazuhisa TsurutaHirotomo Shimizu
    • Masaki YuiAkira YokozawaTomoyo MurataKazuhisa TsurutaHirotomo Shimizu
    • C12N900
    • A61K9/0019A61K38/00A61K47/02A61K47/12A61K47/26A61K47/44C07K14/7455Y10S514/822
    • A method for keeping the quality of an aqueous parenteral solution of thrombomodulin which is not in a frozen or freeze-dried state but in a liquid form in storage and distribution, characterized in that the aqueous thrombomodulin solution containing an effective amount of soluble thrombomodulin and a buffer component exhibiting a buffering activity in a pH range of 5 to 7.0 has a pH of 5 to 7.0 and that (a) the aqueous thrombomodulin solution further contains a surfactant and is in a state aseptically filled into a case or (b) the aqueous thrombomodulin solution is the form of a prefilled syringe preparation produced by aseptically filling the thrombomodulin solution into a syringe substantially without any empty space. This method provides for the storage and distribution of an aqueous parenteral solution of thrombomodulin in a liquid state for a prolonged period and makes it possible to provide an aqueous parenteral solution which is excellent in long-term stability and shaking stability and can save the trouble of dissolving in use.
    • 一种保持不是冷冻或冷冻干燥状态而是液体形式的血栓调节蛋白的水性肠胃外溶液的储存和分配的质量的方法,其特征在于含有有效量的可溶性血栓调节蛋白和 在5〜7.0的pH范围内表现出缓冲活性的缓冲成分的pH为5〜7.0,(a)血栓调节素水溶液还含有表面活性剂,处于无菌填充状态的状态,或(b) 血栓调节蛋白溶液是通过将基本上没有任何空白空间无菌地将血栓调节蛋白溶液注入注射器而制备的预充式注射器制剂的形式。 该方法提供长时间稳定的液体状态的血栓调节蛋白的肠胃外水溶液的储存和分配,能够提供长期稳定性和摇晃稳定性优异的水性肠胃外溶液,并且可以节省 溶于使用。