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2014, v.42;No.504(06) 75-79

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药品冻干工艺过程分析技术研究进展
Progress in Process Analytical Technologies for Freeze-drying of Pharmaceutical

郭彦伟;李保国;郭柏松;杨春生;杨智;
GUO Yan-wei;LI Bao-guo;GUO Bai-song;YANG Chun-sheng;YANG Zhi;University of Shanghai for Science and Technology;Shanghai Tofflon Science & Technology Co.Ltd.;

摘要(Abstract):

现代药品冻干生产的质量控制模式,正从"检验决定质量"向"质量源于设计"模式发展。"过程分析技术"是实施"质量源于设计"理念的有效工具,本文综述了药品冻干"过程分析技术"新进展,对应用于药品冻干工艺开发及生产过程中的"过程分析技术"原理和特点进行了分析,这些过程分析新技术,能够对冻干过程关键参数进行实时监控,保证工艺输出质量,带来药品冷冻干燥技术创新。
In freeze-drying production,the mode of controlling pharmaceutical quality has been developed from "Quality by Test"to"Quality by Design"."Process Analytical Technology"is the key tools which can help implement the core philosophy of"Quality by Design".Several novel process analytical technologies which are applied to the pharmaceutical freeze-drying industry are summarized and analyzed.Several novel process analytical technologies which are applied to the pharmaceutical freeze-drying industry are summarized and analyzed.It is emphasized that the process analytical technologies will be joint utilized monitoring critical process parameters during freeze-drying processing to ensure the quality of process outputs.

关键词(KeyWords): 冷冻干燥;过程分析技术;质量源于设计
freeze-drying;process analytical technology;quality by design

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基金项目(Foundation): 上海市农业成果转化项目(113919N0400);上海市农业成果转化项目(113919N0400);; 上海市联盟计划项目(LM201364)

作者(Author): 郭彦伟;李保国;郭柏松;杨春生;杨智;
GUO Yan-wei;LI Bao-guo;GUO Bai-song;YANG Chun-sheng;YANG Zhi;University of Shanghai for Science and Technology;Shanghai Tofflon Science & Technology Co.Ltd.;

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