| 药用辅料行业发展现状分析与思考 |
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| 引用本文： | 冯巧巧,谢纪珍,孙利民,樊红延,张力. 药用辅料行业发展现状分析与思考[J]. 中国药事, 2018, 32(1): 54-58 |
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| 作者姓名： | 冯巧巧 谢纪珍 孙利民 樊红延 张力 |
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| 作者单位： | 山东省食品药品监督管理局审评认证中心, 济南 250014,山东省食品药品监督管理局审评认证中心, 济南 250014,山东省食品药品监督管理局审评认证中心, 济南 250014,山东省食品药品监督管理局审评认证中心, 济南 250014,北京中医药大学东方医院, 北京 100078 |
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| 摘 要： | 目的：促进药用辅料行业健康发展，确保药品质量和用药安全。方法：回顾分析我国药品辅料的发展，结合目前国内药用辅料标准收载及药用辅料与药品关联审评对辅料的要求，分析辅料行业存在的问题，提出相关建议和对策。结果与结论：药用辅料行业发展相对落后，提高药用辅料标准，加强辅料的开发和生产应用，是确保药用辅料质量安全的有效措施。
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| 关 键 词： | 药用辅料 行业问题 风险意识 辅料标准 质量监管 对策措施 |
| 收稿时间： | 2017-07-28 |
Analysis and Thoughts on the Current Status of Pharmaceutical Excipient Industry |
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| Feng Qiaoqiao,Xie Jizhen,Sun Limin,Fan Hongyan and Zhang Li. Analysis and Thoughts on the Current Status of Pharmaceutical Excipient Industry[J]. Chinese Pharmaceutical Affairs, 2018, 32(1): 54-58 |
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| Authors: | Feng Qiaoqiao Xie Jizhen Sun Limin Fan Hongyan Zhang Li |
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| Affiliation: | Center for Evaluation and Certification, Shandong Food and Drug Administration, Jinan 250014, China,Center for Evaluation and Certification, Shandong Food and Drug Administration, Jinan 250014, China,Center for Evaluation and Certification, Shandong Food and Drug Administration, Jinan 250014, China,Center for Evaluation and Certification, Shandong Food and Drug Administration, Jinan 250014, China and Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China |
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| Abstract: | Objective: To promote the healthy development of pharmaceutical excipient industry and to ensure drug quality and safety. Methods: The development of China''s pharmaceutical excipient was retrospectively analyzed. Based on the requirements of the current domestic pharmaceutical excipient standards and the joint review of pharmaceutical excipient and drugs, the problems in pharmaceutical excipient industry were analyzed, relevant proposals and countermeasures were put forward. Results and Conclusion: The development of pharmaceutical excipients industry is relatively backward. Therefore, improving the standards of pharmaceutical excipientes and strengthening the development and production of pharmaceutical excipients are effective countermeasures to ensure the quality and safety of pharmaceutical excipients. |
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| Keywords: | pharmaceutical excipient industry problem risk awareness excipient standard quality control countermeasures |
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