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    • 1. 发明申请
    • STABILIZED SINGLE-LIQUID PHARMACEUTICAL COMPOSITION CONTAINING DOCETAXEL
    • 含有多西他赛的稳定的单一液体药物组合物
    • WO2009107983A3
    • 2009-12-03
    • PCT/KR2009000911
    • 2009-02-26
    • DONG A PHARM CO LTDYOO MOO-HICHA BONG-JINKIM JEONG-HOONJANG SUN-WOOWON DONG-HAN
    • YOO MOO-HICHA BONG-JINKIM JEONG-HOONJANG SUN-WOOWON DONG-HAN
    • A61K9/08A61K31/337A61K47/08A61P35/00
    • A61K9/0019A61K47/26
    • The present invention relates to a liquid pharmaceutical composition for injection containing docetaxel. The composition of the present invention contains (A) docetaxel and a pharmaceutically acceptable salt, (B) a surface active agent selected from polysorbate, polyoxyethylene glycol ester and polyoxyethylene castor oil derivatives, (C) a solvent containing anhydrous ethanol in the range of concentration of 100 to 800mg/ml in an injection solution, and (D) a pH adjuster of the amount suitable for adjusting pH of the liquid composition to 5 or lower. The composition of the present invention can be directly diluted in a perfusion liquid even without using an intermediary dilute solution in cases where the composition of the present invention is used as injectable preparations as the composition is formed into a single liquid phase. Further, the composition of the present invention is suitable for effective injection of docetaxel as the pharmaceutical stability of the composition is significantly improved.
    • 本发明涉及含有多西他赛的注射用液体药物组合物。 本发明的组合物含有(A)多西紫杉醇及其药学上可接受的盐,(B)选自聚山梨酸酯,聚氧乙烯乙二醇酯和聚氧乙烯蓖麻油衍生物的表面活性剂,(C)含有浓度范围的无水乙醇的溶剂 (D)适于将液体组合物的pH调节至5或更低的量的pH调节剂。 在本发明的组合物用作可注射制剂的情况下,即使不使用中间稀释溶液,本发明的组合物也可以在灌注液中直接稀释,因为组合物形成单一液相。 此外,由于组合物的药物稳定性显着改善,本发明的组合物适合有效注射多西紫杉醇。