| 注射用辅料类过敏反应的非临床评价方法 |
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| 引用本文： | 李佳,黄芝瑛. 注射用辅料类过敏反应的非临床评价方法[J]. 药物评价研究, 2010, 0(1): 9-12 |
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| 作者姓名： | 李佳 黄芝瑛 |
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| 作者单位： | 中山大学药学院药物安全性评价中心,广东广州510006 |
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| 基金项目： | 基金来源：科技部“十一五”国家科技支撑计划重点项目--药用新辅料临床前安全性评价及药品与包装材料的相容性安全研究（2008BA155B03） |
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| 摘 要： | 近年来注射剂的安全性问题引起了社会各界的广泛关注,注射用辅料引发的类过敏反应是导致注射剂临床使用安全隐患的主要原因之一,而目前尚未建立完善的可用于评价注射用辅料类过敏反应的非临床研究方法。对近年来国内外在该方面的研究进展做一综述,旨在为注射用辅料类过敏反应非临床评价方法的发展提供一些帮助和启示。
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| 关 键 词： | 补体激活 组胺释放 注射用辅料 类过敏反应 |
Non-clinical evaluation on pseudoallergy induced by injective excipient |
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| LI Jia,HUANG Zhi-ying. Non-clinical evaluation on pseudoallergy induced by injective excipient[J]. Drug Evaluation Research, 2010, 0(1): 9-12 |
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| Authors: | LI Jia HUANG Zhi-ying |
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| Affiliation: | (Center of Safety Evaluation on New Drug, School of Pharmaceutical Science, Sun Yat-sen University, Guangdong Guangzhou 510006, China) |
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| Abstract: | The safety issues of injection have evoked more public concern recently. Pseudoallergy induced by injective excipient is one of the main causes. However, non-clinical evaluation methods for this have not yet developed well. This paper reviewed the progress in this field in order to get more recognition for non-clinical evaluation of pseudoallergy induced by injective excipient. |
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| Keywords: | complement activation histamine release injective excipient pseudoallergy |
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