| 药品生产中水的质量控制 |
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| 引用本文： | 李华,徐琼芳,周玉波,谢忠平,柯华昕,唐桂珍. 药品生产中水的质量控制[J]. 中国药业, 2007, 16(23): 35-36 |
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| 作者姓名： | 李华 徐琼芳 周玉波 谢忠平 柯华昕 唐桂珍 |
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| 作者单位： | 中国医学科学院中国协和医科大学医学生物学研究所,云南,昆明,650118 |
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| 摘 要： | 目的考察水作为药品生产特别是生物制品生产中的主要原辅材料的质量。方法按2005年版《中国药典（二部）》收载的注射用水检测项目进行相关检测。结果对2004—2006年水的质量进行检测及质量控制，并对以水为原辅料生产的终产品进行质量检定，注射用水的质量符合《中国药典（二部）》要求。结论所生产的注射液用水是优质的，可以用于药品生产。
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| 关 键 词： | 水 药品生产 注射用水 质量控制 |
| 文章编号： | 1006-4931(2007)23-0035-02 |
| 修稿时间： | 2007-03-27 |
Quality Control of Water Used in Pharmaceutical Manufacture |
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| Li Hua,Xu Qiongfang,Zhou Yubo,Xie Zhongping,Ke Huaxin,Tang Guizhen. Quality Control of Water Used in Pharmaceutical Manufacture[J]. China Pharmaceuticals, 2007, 16(23): 35-36 |
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| Authors: | Li Hua Xu Qiongfang Zhou Yubo Xie Zhongping Ke Huaxin Tang Guizhen |
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| Affiliation: | Li Hua, Xu Qiongfang, Zhou Yubo, Xie Zhongping, Ke Huaxin, Tang Guizhen ( lastitute of Medical Biology, Peking Union Medical College, Chinese Academy of Medical Science, Kunming, Yunnan, China 650118) |
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| Abstract: | Objective To investigate the quality of sterilized water used in the production of biologicals as a raw material. Methods The item of quality control performed is accorded with the standard of Chinese Pharmacopoeia （2005 Ⅱ）.Results The quality detection and control depending upon the sample from production and final product respectively confirmed that the sterilized water used in Institute of Medicine Biology （IMB） was accordance with the standard of Chinese Pharmacopoeia, Conclusion The sterilized water used in IMB possesses excellent quality for the production of biologicals. |
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| Keywords: | water pharmaceutical manufacture water for injection quality control |
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