YAN, GUANGMEI,HU, HAIYAN,ZHANG, JINGXIA,QIU, PENGXIN,LI, LING,TIAN, NING
申请号:
SG2013016126
公开号:
SG188393A1
申请日:
2011.07.08
申请国别(地区):
SG
年份:
2013
代理人:
摘要:
5α-ANDROSTANE-3ß,5,6ß-TRIOL INJECTION AND PREPARATION METHOD THEREFOR ABSTRACTA 5α-androstane-3ß,5,6ß-triol injection and its preparation are disclosed. The injection uses hydroxypropy1-ß-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-ß-cyclodextrin. The injection may also comprise 1-100 parts of an isotonic adjusting agent, 0-200 parts of a freeze drying filler, and 0-2000 parts of a solvent. The preparation method comprises dissolving hydroxypropy1-ß-cyclodextrin solution, 5α-androstane-3ß,5,6ß-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.