| 中药化学对照品标定常见问题分析 |
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| 引用本文： | 刘静,何轶,张聿梅,戴忠,马双成.中药化学对照品标定常见问题分析[J].中国药事,2017,31(10):1171-1175. |
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| 作者姓名： | 刘静 何轶 张聿梅 戴忠 马双成 |
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| 作者单位： | 中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050,中国食品药品检定研究院, 北京 100050 |
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| 摘 要： | 目的：分析中药化学对照品标定过程中的常见问题，探讨相应的解决方案。方法：根据标定过程中结构鉴定、纯度分析、水分测定、残留溶剂、无机盐、定值等环节存在的不同问题进行个性化分析，分类总结。结果：通过对中药化学对照品标定过程中常见问题的分析，提出了相应的解决方案。结论：有关问题的解决为中药化学对照品的标定和使用提供了有利的技术支持。
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| 关 键 词： | 中药化学对照品 结构鉴定 标定赋值 质量平衡法 核磁共振法 |
| 收稿时间： | 2017/6/23 0:00:00 |
Analysis of Common Problems in Standardization of Traditional Chinese Medicine Chemical Reference Substance |
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| Liu Jing,He Yi,Zhang Yumei,Dai Zhong and Ma Shuangcheng.Analysis of Common Problems in Standardization of Traditional Chinese Medicine Chemical Reference Substance[J].Chinese Pharmaceutical Affairs,2017,31(10):1171-1175. |
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| Authors: | Liu Jing He Yi Zhang Yumei Dai Zhong and Ma Shuangcheng |
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| Institution: | National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China,National Institutes for Food and Drug Control, Beijing 100050, China and National Institutes for Food and Drug Control, Beijing 100050, China |
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| Abstract: | Objective: To analyze the common problems in standardization of traditional Chinese medicine chemical reference substance (TCMCRS) and to discuss the corresponding solutions. Methods: Different problems existing during the process of standardization, such as structural identification, purity analysis, moisture determination, residual solvent, inorganic salt, and calibration assignment were specifically analyzed, classified and summarized. Results: The common problems in standardization of TCMCRS were summarized and corresponding solutions were put forward. Conclusion: Solutions to the problems provided strong technical support for the standardization and practical use of TCMCRS. |
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| Keywords: | traditional Chinese medicine chemical reference substance structure identification calibration assignment mass balance method nuclear magnetic resonance |
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