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    • 8. 发明申请
    • A CO-SPRAY DRIED COMPOSITION OF CEFEPIME WITH BASE AND PROCESS FOR PREPARATION THEREOF
    • 具有基础的CO喷雾干燥组合物及其制备方法
    • WO2006106529A1
    • 2006-10-12
    • PCT/IN2006/000114
    • 2006-04-03
    • LUPIN LIMITEDTYAGI, Om, DuttCHAUHAN, Yogendra, KumarMEHARE, Kishor, Gulabrao
    • TYAGI, Om, DuttCHAUHAN, Yogendra, KumarMEHARE, Kishor, Gulabrao
    • C07D501/00A61K31/545
    • C07D501/00
    • Stable and sterile composition of cefepime and a process for preparing the same. Amorphous composition containing cefepime acid addition salt or solvates thereof and organic or inorganic base obtained by spray drying of their aqueous solution. The process comprises dissolving a composition containing mixture of cefepime acid addition salt and a pharmaceutically acceptable non-toxic organic or inorganic base in water to obtain aqueous solution, filtration of aqueous solution through 0.2 micron membrane filter and subjecting the clear aqueous solution to spray drying, or dissolving a cefepime acid addition salt in water, dissolving a pharmaceutically acceptable non-toxic organic or inorganic base in water, addition of solution from operation (v) to solution from operation (iv) at 0-30°C, preferably at 0-10°C to obtain a solution having a pH in the range of 3.0-7.0, filtration of aqueous solution through 0.2 micron membrane filter, and subjecting the clear aqueous solution to spray drying.
    • 头孢吡肟的稳定无菌组合物及其制备方法。 含有头孢吡肟酸加成盐或溶剂合物的无定形组合物和通过其水溶液的喷雾干燥获得的有机或无机碱。 该方法包括将含有头孢吡肟酸加成盐和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在水中以获得水溶液,通过0.2微米膜过滤器过滤水溶液并使透明水溶液喷雾干燥, 或将头孢吡肟酸加成盐溶解在水中,将药学上可接受的无毒有机或无机碱溶解在水中,在操作(v)中加入溶液至0-30℃,优选0〜 10℃,得到pH范围为3.0-7.0的溶液,通过0.2微米膜过滤器过滤水溶液,并对透明水溶液进行喷雾干燥。