西林瓶装注射用水的装量检查分析

为了检查西林瓶装注射用水的实际分装量是否符合2005年版《药典》三部要求，按照2005年版《药典》三部中“生物制品分装和冻干规程”，分装规格为0．8ml的西林瓶装注射用水10000瓶，随机在分装过程的前、中、后阶段共抽取100瓶，轧盖、目检。分别用1ml标定注射器及1ml普通无菌注射器抽取每瓶注射用水的实际体积，以t检验法对实际抽取量与标示量的差值进行统计学分析，结果显示其与2005年版《药典》三部要求分装附加量为0．1ml相比有显著性差异（P〈0．001）。

Analysis of inspection of filling amount of injected water

To determine if the actual filling amount conforms to the requirement of the Pharmacopeia of the third edition in 2005,the 1000 vials injected water with 0.8ml standard were filled,then 100 vials were selected to be capped and be visual inspected during the filling period of the earlier stage,mid-term and later stage randomly.The actual amount of every vial was extracted by 1ml calibrated injector and 1ml normal steriled injector respective.The difference between the actual extracted amount and labeled amou...