| 我国药用辅料现状及国内外监管对比 |
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| 引用本文： | 肖盼盼,刘雁鸣.我国药用辅料现状及国内外监管对比[J].中国药事,2014(2):128-133. |
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| 作者姓名： | 肖盼盼 刘雁鸣 |
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| 作者单位： | [1]中南大学药学院,长沙410013 [2]湖南药用辅料检验检测中心,长沙410013 |
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| 摘 要： | 目的提高我国药用辅料的监管水平。方法分析我国药用辅料现状，对中国、美国、欧洲药用辅料的监管模式进行对比。结果与结论应通过健全药用辅料监管法律法规和质量标准；对药用辅料重新包装和运输过程进行严格的质量控制；逐步实施GMP认证管理等措施，进一步加强药用辅料的监督管理。
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| 关 键 词： | 药用辅料 质量标准 管理模式 比较 |
The Current Situation of Pharmaceutical Excipients in China and the Comparison in Supervision at Home and Abroad |
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| Xiao Panpan and Liu Yanming.The Current Situation of Pharmaceutical Excipients in China and the Comparison in Supervision at Home and Abroad[J].Chinese Pharmaceutical Affairs,2014(2):128-133. |
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| Authors: | Xiao Panpan and Liu Yanming |
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| Institution: | Xiao Panpan and Liu Yanming(1School of Pharmaceutical Sciences, Central South University, Changsha 410013; 2Hunan Inspection and Testing Center of Pharmaceutical Excipients) |
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| Abstract: | Objective To improve the quality of supervision on pharmaceutical excipients in China. Method The current situation of Chinese pharmaceutical excipients was analyzed and the supervision pattern of pharmaceutical excipients in our country was compared with those in America and Europe. Results and Conclusion Through improving supervisory management laws and regulations, and quality standards of pharmaceutical excipients, the repackaging and transport of pharmaceutical excipients should be strictly controlled, and GMP authentication should be conducted gradually, thus strengthening the supervision and management of pharmaceutical excipients. |
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| Keywords: | pharmaceutical excipients quality standards regulatory medel comparison |
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