5a-Androstane-3ß,5,6ß-Triol Injection and Preparation Method Theref48
    2.
    发明申请
    5a-Androstane-3ß,5,6ß-Triol Injection and Preparation Method Theref48 审中-公开
    5α-雄甾烷-3β,5,6β-三醇注射液及其制备方法

    公开(公告)号:US20160051685A1

    公开(公告)日:2016-02-25

    申请号:US14839869

    申请日:2015-08-28

    IPC分类号: A61K47/40 A61K9/00 A61K31/568

    摘要: A 5α-androstane-3β,5,6β-triol injection and its preparation are disclosed. The injection uses hydroxypropyl-β-cyclodextrin as a solubilizing agent and the active ingredient is present at a weight ratio of 1-20:40-500 to the hydroxypropyl-β-cyclodextrin. The injection may also comprise, by weight, 1-100 parts of at least one isotonic adjusting agent, 0-200 parts of at least one freeze drying filler, and 0-2000 parts of at least one solvent. The preparation method comprises dissolving hydroxypropyl-β-cyclodextrin solution, 5α-androstane-3β,5,6β-triol and at least one additional soluble excipient in water for injection in sequence to obtain a raw injection solution, and subjecting the raw injection solution to decolorization, depyrogenation, filtration and sterilization to obtain the injection. Drying the filtrate yields a solid for injection.

    摘要翻译: 公开了5α-雄甾烷-3&bgr,5,6和三烯注射剂及其制备。 注射剂使用羟丙基 - 环糊精作为增溶剂,活性成分以1-20:40-500的重量比与羟丙基-β-环糊精一起存在。 注射剂还可以包含1-100份至少一种等渗调节剂,0-200份至少一种冷冻干燥填料和0-2000份至少一种溶剂。 制备方法包括将羟丙基 - 环糊精溶液,5α-雄甾烷-3β,5,6α-三醇和至少一种额外的可溶性赋形剂在水中依次溶解,得到原始注射液, 注射溶液脱色,去热原,过滤和灭菌获得注射。 干燥滤液得到固体,用于注射。