申请人:I.C.I. International Chemical Industry Spa
公开号:EP1314439A1
公开(公告)日:2003-05-28
A process for the sterilisation of a powder substance is described; in particular, the invention regards the process for the sterilisation of pharmaceutical active principles in powder, including the use of a lyostat in the presence of Hydrogen Peroxide. The invention process makes it possible to sterilise the active principles mentioned without obtaining toxic substances or a change in colour, and without bringing about a decrease in the stability or in the assay of the active principles.
本发明描述了一种粉末物质的灭菌工艺;特别是粉末中药物活性成分的灭菌工艺,包括在过氧化氢存在下使用溶菌剂。本发明的工艺使上述活性成分的灭菌成为可能,同时不会产生有毒物质或颜色变化,也不会降低活性成分的稳定性或检测能力。