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影响生物制品冻干粉针剂水分的探讨
引用本文:陈哲文,张亚达,秦洁,黄颖华,陈文杰,姜大忠,程惠蓉.影响生物制品冻干粉针剂水分的探讨[J].微生物学免疫学进展,2002,30(4):44-47.
作者姓名:陈哲文  张亚达  秦洁  黄颖华  陈文杰  姜大忠  程惠蓉
作者单位:上海生物制品研究所,上海,200051
摘    要:探讨生物制品冻干粉针剂样品放置一时间后残余水分增高的原因。进行了水分测定,真空度检测,二甲硅油和丁基橡胶药用瓶塞干燥失重的检测。冻干后每只丁基橡胶药用瓶塞平均含水分0.00224g。结果表明丁基橡胶药用瓶塞灭苗,干燥和冻干过程中去除水分不彻底是引起样品中水分升高的直接原因。

关 键 词:生物制品  冻干粉针剂  水分  冻干  丁基橡胶药用瓶塞
文章编号:1005-5673(2002)-04-0044-04
修稿时间:2002年3月25日

Investigation on the effect on moisture content of freeze-dried powder of biological products
CHEN Zhe-wen,ZHANG Ya-da,QIN Jie et al..Investigation on the effect on moisture content of freeze-dried powder of biological products[J].Progress In Microbiology and Immunology,2002,30(4):44-47.
Authors:CHEN Zhe-wen  ZHANG Ya-da  QIN Jie
Abstract:To study the causes of increasing moisture content in freeze dried powder of biological products after been laying a period by moisture control test, the tests for moisture content,vacuum weight loss on drying of dimethicone and rubber stopper of vial were performed. Average moisture content of a rubber stopper was 0.00224g after freeze-dried. The increasing moisture content of samples was due to the incompletely removal of the moisture of rubber stopper during sterilizing, drying and freeze-drying process.
Keywords:Freeze-drying  Rubber stopper of vial  Moisture  
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