| 对乙酰氨基酚缓释制剂的安全性研究进展 |
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| 引用本文： | 李春伢,兰静,宗政涛,陈再新. 对乙酰氨基酚缓释制剂的安全性研究进展[J]. 现代药物与临床, 2019, 42(6): 1250-1256 |
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| 作者姓名： | 李春伢 兰静 宗政涛 陈再新 |
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| 作者单位： | 亚邦医药研究院, 江苏 常州 213100,天津市药品审评中心, 天津 300000,亚邦医药研究院, 江苏 常州 213100,亚邦医药研究院, 江苏 常州 213100 |
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| 摘 要： | 近年来，欧盟因为对乙酰氨基酚缓释制剂的安全性问题已经暂停其在欧盟国家的销售，目前国内对于对乙酰氨基酚缓释制剂的安全性罕见报道。结合对乙酰氨基酚缓释制剂的发展历史，对正常剂量和过量使用对乙酰氨基酚缓释制剂、曲马多-对乙酰氨基酚复方缓释制剂的安全性和药动学参数等方面进行详细论述，为含对乙酰氨基酚的缓释制剂的安全性评价和合理应用提供参考。
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| 关 键 词： | 对乙酰氨基酚 缓释制剂 治疗剂量 过量使用 药品安全 |
| 收稿时间： | 2018-12-19 |
Research progress on safety of sustained release formulation of paracetamol |
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| LI Chuny,LAN Jing,ZONG Zhengtao and CHEN Zaixin. Research progress on safety of sustained release formulation of paracetamol[J]. Drugs & Clinic, 2019, 42(6): 1250-1256 |
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| Authors: | LI Chuny LAN Jing ZONG Zhengtao CHEN Zaixin |
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| Affiliation: | Yabang Medical Research Institute, Changzhou 213100, China,Tianjin Center for Drug Evaluation, Tianjin 300000, China,Yabang Medical Research Institute, Changzhou 213100, China and Yabang Medical Research Institute, Changzhou 213100, China |
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| Abstract: | In recent years, sustained release formulation of paracetamol has been discontinued in EU market because of its safety issue, but the safety of this drug is rarely reported in China. This review expounds the safety as well as pharmacokinetics parameters of sustained release paracetamol formulation and extended release tramadol/paracetamol formulation following therapeutic dose and overdose combining with the history of drug development,which provide a clue for safety evaluation and rational use of these drugs. |
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| Keywords: | paracetamol sustained release formulation therapeutic dose overdose safety of drug |
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