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中国医药导刊 ›› 2022, Vol. 24 ›› Issue (5): 446-449.

• 专栏:医疗机构中药制剂 • 上一篇    下一篇

浅谈医院制剂的发展现状

丘振文1, 周本杰2, 唐洪梅1, 蔡庆群1, 张晓婷1, 章秀冰1, 杨忠奇1*   

  1. 1.广州中医药大学第一附属医院, 广东 广州 510405;  2. 中山大学附属第七医院, 广东 深圳 518000
  • 收稿日期:2022-07-19 出版日期:2022-05-28 发布日期:2022-05-28
  • 基金资助:
    广州市科技计划项目(项目编号:202102010013;项目名称:中药早期临床研究重点实验室)

Development Situation of Hospital Preparations

  1. 1.The Frist Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Guangzhou 510405, China;  2.The Seventh Affiliated Hospital of Sun Yat-sen University, Guangdong Shenzhen 518000, China
  • Received:2022-07-19 Online:2022-05-28 Published:2022-05-28

摘要: 目的:分析医院制剂发展现状,为医院制剂的管理与发展提供参考。方法:梳理医院制剂生产设备及环境、制剂人才队伍建设、制剂类型及品种、质量管理与注册申报、新药转化情况,浅谈医院制剂发展现状,依据当前国家相关法规及医药学研究领域的最新动态,提出发展策略。结果和结论:新形势下,医院制剂发展面临诸多挑战。结合我院经验和做法提出建议,通过转变发展思路,在政策指引下不断完善自身生产硬件和管理软件等设施,提高医疗机构对医院制剂重要性的认识,利用好中医药发展的良好环境,发挥好医院制剂特色优势,积极发展中医优势病种的特色中药制剂,提高医院制剂质量,加强新制剂研发,开展临床观察及不良反应监测,通过制定专家共识,强化医院制剂配制与质量管理规范化,推进医院制剂研发工作发展。

关键词: font-size:medium, ">医院制剂;中药制剂;发展现状;发展思路;质量管理

Abstract: Objective:To analyze the development situation of hospital preparations, and to provide reference for the development and management of hospital preparations.Methods:The related situations on the production equipment and environment, talent team building, types and varieties,quality management and registration application,new drug transformation of hostpital preparations were sorted out, the current situation on the development of hospital preparation was briefly discussed, and the development strategy was put forward according to the current national regulations and the latest trends in the field of pharmaceutical research. Results & Conclusion: The development of hospital preparations in medical institutions is facing severe challenges under the new situation. It is suggested that by shifting the development thinking, under the guidance of policies, constantly improve the production hardware and management software and other conditions,improve the awareness of healthcare institutions on the importance of hospital preparations,make good use of the favorable environment for the development of traditional Chinese medicine (TCM), give full play to the advantages of hospital preparations,actively develop the characteristic TCM preparations for the dominant diseases of TCM,improve the quality of hospital preparations, strengthen the research and development of new preparations, carry out clinical observation and monitoring of adverse reactions,strengthen the standardization of preparation preparation and quality management in medical institutions through developing expert consensus,and promote the research and development of hospital preparations.

Key words: font-size:medium, ">Hospital preparation, Traditional Chinese medicine preparations, Development situation;Development strategy, Quality management

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