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Home > Wen Yuan (Middle School Edition) > 2018 No.11 > 无菌药品除菌用滤芯的考察

  • 无菌药品除菌用滤芯的考察

    Author(s)：

    李娜 韩建军

    Publication Title：

    Wen Yuan (Middle School Edition) 2018 No.11

    Affiliations：

    华北制药金坦生物技术股份有限公司 河北 石家庄 050035

    Abstract：

    无菌药品通过多种方式来保证其无菌状态,一般分为最终灭菌和非最终灭菌.非最终灭菌药品多数通过使用滤芯通过过滤除菌达到无菌状态.除菌过滤滤芯与最终产品的料液直接接触,其对药品质量起到至关重要的作用.滤芯与药品应通过一系列的试验来考察是否可用于该产品的除菌.主要考察包括细菌截留能力、与药品的化学兼容性、滤芯的可提取物和浸出物、滤芯的安全性评价以及滤芯对药品的吸附性.

    Keywords：

    除菌滤芯;化学兼容性;吸附性;全性评价;可提取物

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    [1] 李娜,韩建军.无菌药品除菌用滤芯的考察[J].Wen Yuan (Middle School Edition),2018(11),.

文渊(中学版)
Wen Yuan (Middle School Edition)

Language: 中文

CN：11-9275/G

ISSN：2096-627X

Publication Frequency: 月刊

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