| 溶媒结品型无菌原料药车间布局要点与典型工艺技术 |
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| 引用本文： | 李向科,姚雪坤. 溶媒结品型无菌原料药车间布局要点与典型工艺技术[J]. 医药工程设计, 2013, 0(6): 10-17 |
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| 作者姓名： | 李向科 姚雪坤 |
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| 作者单位： | [1]中核第四研究设计工程有限公司,石家庄050021 [2]石药集团中奇制药技术（石家庄）有限公司,石家庄050035 |
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| 摘 要： | 针对生产过程使用易燃易爆溶媒和大宗固体物料输送的特性，结合国家相关设计规范，分析了在进行溶媒结晶型无菌原料药车间设计时需要重点考虑的布局要点；对近年来无菌原料药生产过程出现的几种典型技术进行了阐述和总结，并指出新技术的发展方向。
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| 关 键 词： | 溶媒结晶型无菌原料药 无菌药品 车间布局 隔离器 |
Key Points in Disposition for Sterile Menstruum-crystallization Activepharmaceutical-ingredient Workshop and Typical Process Technology |
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| Li Xiangke,Yao Xuekun. Key Points in Disposition for Sterile Menstruum-crystallization Activepharmaceutical-ingredient Workshop and Typical Process Technology[J]. Pharmaceutical Engineering Design, 2013, 0(6): 10-17 |
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| Authors: | Li Xiangke Yao Xuekun |
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| Affiliation: | 1. The Fourth Research and Design Engineering Corporation of CNNC, Shijiazhuang, 050021; 2. CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co., Ltd, Shijiazhuang, 050035) |
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| Abstract: | Based on the fact that in production flammable menstruum is used and with respect to the features of transportation for large amount of solid material, and also combined with relevant design code, the key points in disposition of sterile menstruun-crystallization active-pharmaceutical-ingredient workshop was analyzed in this article. Several typical technologies, which has appeared in recent years, used in the production of sterile active-pharmaceutical-ingredient were described and summarized, and the trend of new technology development was forecasted. |
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| Keywords: | sterile menstruun-crystallization active-pharmaceutical-ingredient sterile drug disposition of workshop separator |
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