药用辅料行业发展现状分析与思考-中国药事.PDFVIP

54 ·监督管理 · 药用辅料行业发展现状分析与思考 1 1 1 1 2 （1. 山东省食品药品监督管理局审评认证中 冯巧巧 ，谢纪珍 ，孙利民 ，樊红延 ，张力 心，济南 250014；2. 北京中医药大学东方医院，北京 100078） 摘要 目的： 方法： 促进药用辅料行业健康发展，确保药品质量和用药安全。 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。 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 R95 A 1002-7777(2018)01-0054-05 中图分类号： 文献标识码： 文章编号： doi:10.16153/j.1002-7777.2018.01.010 Analysis and Thoughts on the Current Status of Pharmaceutical Excipient Industry 1 1 1 1 2 Feng Qiaoqiao , Xie Jizhen , Sun Limin , Fan Hongyan , Zhang Li (1. Center for Evaluation and Certification, Shandong Food and Drug Administration, Jinan 250014, China; 2. Dongfang Hospital, Beijing University of Chinese Medicine, Beijing 100078, China) 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. Keywords: pharmaceutical excipient; industry problem; risk awareness; excipient standard; quality control; countermeasures