摘要
本文对前列腺素E_1无菌静脉注射粉剂及右旋糖苷,β-环糊精(β-CD)两组赋形剂的研究表明:前列腺素E_1无菌冻干静脉注射粉剂的工艺是可行的,两组赋形剂能满足工艺要求。产品通过药理活性、毒性、热原及理化实验,无菌检查合格。
Preparation of the aseptic frozen-dried powder of intravenous injection of PGE_1 and its two excipients is reported.The PGE_1 was seperated by using the silica gel column chromatogr aphy and silver nitrate silica gel column chromatography.The drug was appended by excipient and charged into ampules.Through freeze-drying, perfusing nitrogen gas, sealing the mouth of bottle, the aseptic frozen-dried powder of intravenous injection of PGE_1 was preparated.Undergoing tests of pharmacology activity, toxicity, pyrogen and physics-chemistry, the product was Up to standard,and entered to clinical observation.The research showed that technics of the preparation is practicable, and two excipients can satisfy the technologic request.
出处
《贵阳医学院学报》
CAS
1990年第1期33-36,共4页
Journal of Guiyang Medical College
