| 药物杂质研究现状概述 |
| 投稿时间：2013-11-06 修订日期：2014-01-16 点此下载全文 |
| 引用本文：李娜,娄子洋.药物杂质研究现状概述[J].药学实践杂志,2014,32(3):179~185 |
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| 中文摘要:药品是一种特殊商品,与人们的健康和生命安全息息相关,药物杂质是影响药物稳定性和疗效的物质,与药品质量、安全性及效能密切相关。随着杂质控制在药物开发研究中越来越受到重视,研究者开始将注意力转移到痕量杂质的分析上。笔者总结近10年来国内外杂质研究的相关进展,内容涉及药物杂质研究的相关指导原则、杂质定性研究的相关技术以及杂质定量研究等的一般方法。 |
| 中文关键词:杂质 指导原则 研究技术 综述 |
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| Overview of the research on drug impurity |
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| Abstract:As special commodities, drugs had closely relationships with human beings' health and life safety. Impurity, which would influence the stability and efficacy of drugs, was closely related to the quality, safety and efficacy of drugs. With more and more attendance had been attached to the impurity's control in the development of drugs, researchers turned their attentions to the analysis of trace impurity. In this paper, related progresses in recent 10 years were summarized, including guiding principles in impurity research, technologies in qualitative research and general approaches in quantitative research. |
| keywords:impurity guiding principles research technologies review |
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