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    • 2. 发明申请
    • OXALIPLATIN PHARMACEUTICAL COMPOSITION WITH ALCOHOLIC SUGAR-BASED BUFFER
    • 含有酒精基糖的缓冲剂的奥沙利铂药物组合物
    • WO2008089709A3
    • 2009-06-18
    • PCT/CZ2008000006
    • 2008-01-10
    • PLIVA LACHEMA ASZALUDEK BOREKZATLOUKALOVA LIBUSEZAK FRANTISEKMATEJKOVA BOZENATKADLECKOVA HANA
    • ZALUDEK BOREKZATLOUKALOVA LIBUSEZAK FRANTISEKMATEJKOVA BOZENATKADLECKOVA HANA
    • A61K9/08A61K9/00A61K31/282A61K47/26
    • A61K9/0019A61K31/282A61K47/12
    • A pharmaceutical composition, intended particularly for potential administration and for treatment of tumor diseases sensitive to oxaliplatinum, comprises oxaliplatinum as the active compound, a pharmaceutically acceptable aqueous solvent and a stabilizing agent in stabilizingly effective amount. The stabilizing agent includes at least one compound selected from the group consisting of acids derived from neutral alcoholic sugars, lactones of these acids and salts of these acids. In a method of producing such a pharmaceutical composition, oxaliplatinum is dissolved in an aqueous solvent, whereupon to the obtained oxaliplatinum solution is added at least one acid derived from a neutral alcoholic sugar and/or at least one lactone of these acids and/or at least one salt of these acids, and optionally the pH value of the solution is adjusted by addition of an alkali metal hydroxide and/or an alkali earth metal hydroxide to pH 3.5 - 6.5, whereupon the obtained solution is sterilized and filled into individual package units and optionally inertized with nitrogen or argon.
    • 特别用于潜在给药和治疗对奥沙利铂敏感的肿瘤疾病的药物组合物包含奥沙利铂作为活性化合物,药学上可接受的水性溶剂和稳定有效量的稳定剂。 稳定剂包括选自由中性酒精糖衍生的酸,这些酸的内酯和这些酸的盐中的至少一种化合物。 在制备这种药物组合物的方法中,将奥沙利铂溶解在水性溶剂中,然后向得到的奥沙利铂溶液中加入至少一种衍生自中性酒精糖和/或这些酸的至少一种内酯的酸和/或 这些酸的至少一种盐,并且任选地通过将碱金属氢氧化物和/或碱土金属氢氧化物加入到pH 3.5-6.5来调节溶液的pH值,由此将所得溶液灭菌并填充到各个包装单元 并任选地用氮气或氩气惰性化。