| 药用辅料中人工合成着色剂的标准体系现状分析 |
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| 引用本文： | 李湘平,李汶. 药用辅料中人工合成着色剂的标准体系现状分析[J]. 中国医药指南, 2013, 0(11): 464-466 |
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| 作者姓名： | 李湘平 李汶 |
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| 作者单位： | 1. 汕头大学医学院第二附属医院,广东 汕头 515041
2. 汕头市药品检验所,广东 汕头 515041 |
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| 基金项目： | 2011年度汕头市社会发展攻关计划项目（编号：133） |
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| 摘 要： | 对药用辅料中人工合成着色剂的标准体系现状进行梳理,对存在问题进行分析,为加强药用辅料中人工合成着色剂监管提供技术参考。通过对人工合成着色剂产品标准的颁布年限、发布部门、标准范围、重金属等有害物质的控制情况进行比较,结合现行的法律法规体系,分析人工合成着色剂作为药用辅料在实际监管工作中存在的问题。建设药用辅料中人工合成着色剂标准体系,对科学监管具有重要的现实意义。
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| 关 键 词： | 药用辅料 人工合成着色剂 标准体系 分析 |
Analysis the Present Standard System of Synthetic Colorants for Pharmaceutical Excipients |
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| LI Xiang-ping,LI Wen. Analysis the Present Standard System of Synthetic Colorants for Pharmaceutical Excipients[J]. Guide of China Medicine, 2013, 0(11): 464-466 |
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| Authors: | LI Xiang-ping LI Wen |
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| Affiliation: | 2 (1 Shantou University Medical College Second Affiliated Hospital, Shantou 515041, China; 2 Drug Control of Shantou, Shantou 515041, China) |
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| Abstract: | Carding the present situation of synthetic colorants standard system for pharmaceutical excipients and analysis the existing problems. In order to providing technical reference for strengthen the supervision of synthetic colorants. Comparing the synthetic colorants product standards in the promulgated time ,issued departments, scope of application, heavy metals and other harmful substances＇ assay. Combining the current laws and regulations system, analysis the problems existing in the actual supervision work which about the synthetic colorants using as pharmaceutical excipients. Constructing the synthetic colorants standard system for pharmaceutical excipients is significantly and pratical. |
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| Keywords: | Pharmaceutical excipients Synthetic colorants Standard system Analysis |
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