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    • 3. 发明申请
    • A CO-PRECIPITATED CEFEPIME COMPOSITION AND PROCESS FOR PREPARATION THEREOF
    • 共沉淀的头峰组合物及其制备方法
    • WO2005094800A3
    • 2005-11-24
    • PCT/IN2005000095
    • 2005-03-30
    • LUPIN LTDTYAGI OM DUTTCHAUHAN YOGENDRA KUMARSRIVASTAVA TUSHAR KUMAR
    • TYAGI OM DUTTCHAUHAN YOGENDRA KUMARSRIVASTAVA TUSHAR KUMAR
    • A61K31/546C07D501/00
    • A61K31/546
    • The present invention provides a stable and sterile composition of Cefepime with a pharmaceutically acceptable non-toxic organic and inorganic base in high purity which exhibits good thermal stability which is obtained by co precipitation of composition containing non-sterile Cefepime and non-sterile pharmaceutically acceptable base. The method of preparing the co-precipitated composition of Cefepime with pharmaceutically acceptable non-toxic base comprises of, i) dissolving a composition containing mixture of non sterile Cefepime and a non sterile pharmaceutically acceptable non-toxic organic or inorganic base in water to obtain a clear aqueous solution having a pH in the range of 3.5-7 and ii) filtration of aqueous solution through 0.2 micron membrane filter and then adding the clear aqueous solution to a suitable an organic solvent followed by stirring, filtration and drying.
    • 本发明提供了具有高纯度的药学上可接受的无毒有机和无机碱的稳定且无菌的头孢吡肟组合物,其显示出良好的热稳定性,其通过共沉淀包含非无菌头孢吡肟和非无菌药学上可接受的碱 。 制备头孢吡肟与药学上可接受的无毒碱的共沉淀组合物的方法包括:i)将含有非无菌头孢吡肟和非无菌药学上可接受的无毒有机或无机碱的混合物的组合物溶解于水中以获得 澄清的pH值为3.5-7的水溶液,和ii)通过0.2微米膜过滤器过滤水溶液,然后将澄清的水溶液加入合适的有机溶剂中,随后搅拌,过滤并干燥。