Yan, Guangmei,Hu, Haiyan,Zhang, Jingxia,Qiu, Pengxin,Li, Ling,Tian, Ning
申请号:
HRP20181002
公开号:
HRP20181002T1
申请日:
2018.06.28
申请国别(地区):
HR
年份:
2018
代理人:
摘要:
A 5±-androstane-3²,5,6²-triol injection and its preparation are disclosed. The injection uses hydroxypropyl-²-cyclodextrin as a solubilizing agent and the active ingredient is present in a part by weight ratio of 1-20:40-500 to the hydroxypropyl-²-cyclodextrin. The injection may also comprise 1ˆ¼100 parts of an isotonic adjusting agent, 0ˆ¼200 parts of a freeze drying filler, and 0ˆ¼2000 parts of a solvent. The preparation method comprises dissolving hydroxypropyl-²-cyclodextrin solution, 5±-androstane-3²,5,6²-triol and soluble excipients 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.