Matejtschuk Paul, Rafiq Shakeel, Johnes Suzanne, Gaines Das Rose
National Institute for Biological Standards & Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, UK.
Biologicals. 2005 Jun;33(2):63-70. doi: 10.1016/j.biologicals.2004.12.002.
Lyophilization is a key strategy in the stabilization of biological materials. Protection of the lyophilized material from an oxidizing atmosphere is essential if stability is to be maintained under long term storage. Vials of lyophilized albumin closed by two methods and ampoules of albumin have been examined for moisture and oxygen ingress after storage both under conditions of stress for two months and under thermally accelerated conditions for one year. The results show that the gas and moisture contents of ampoules do not detectably change even under conditions of stress, in contrast to vials for which this study shows clearly detectable moisture ingress and suggests some oxygen ingress. This is consistent with the results of other studies. Thus, although vials may be satisfactory under constrained conditions of temperature and storage for limited periods of time, and are presently used satisfactorily for some working standards, it would be prudent to continue to use ampoules for storage of international reference materials which are intended for indefinite storage and for which stability is an essential requirement.
冻干是生物材料稳定化的关键策略。如果要在长期储存下保持稳定性，保护冻干材料免受氧化气氛的影响至关重要。对通过两种方法封闭的冻干白蛋白小瓶和白蛋白安瓿在两个月的应激条件下和一年的热加速条件下储存后的水分和氧气进入情况进行了检测。结果表明，即使在应激条件下，安瓿中的气体和水分含量也没有明显变化，与此形成对比的是，本研究表明小瓶中有明显可检测到的水分进入，并且提示有一些氧气进入。这与其他研究结果一致。因此，尽管小瓶在有限的温度和储存受限条件下可能在一段时间内令人满意，并且目前在一些工作标准中使用得也令人满意，但对于打算无限期储存且稳定性是基本要求的国际参考物质，继续使用安瓿进行储存将是审慎之举。
