| 齐琪,许保海,陆洋.基于医疗机构中药制剂研发策略与新药转化的思考[J].中国药事,2021,35(12):1357-1363 |
| 基于医疗机构中药制剂研发策略与新药转化的思考 |
| On the Research Strategy and New Drug Transformation of TCM Preparations in Medical Institution |
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| DOI：10.16153/j.1002-7777.2021.12.006 |
| 中文关键词: 医疗机构中药制剂 中药新药 专利 商业秘密 |
| 英文关键词: TCM preparation in medical institution new TCM patent trade secret |
| 基金项目:北京市属医院科研培育计划(编号 PZ2021005) |
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| 中文摘要: |
| 目的：探讨医疗机构中药制剂的新药转化与研发策略。方法：通过对比分析国家发布的医疗机构中药制剂相关管理政策，提出医疗机构中药制剂向中药新药转化的策略以及在此过程中存在的知识产权问题。结果与结论：医疗机构中药制剂是中药新药研发的宝库，我国近年发布的政策文件、医疗机构的积极响应、清晰的开发思路及科学规范的研究都将有助于医疗机构中药制剂的传承、发展和创新。 |
| 英文摘要: |
| Objective: To explore the research and development ideas of new TCM based on TCM preparations in medical institution. Methods: Through comparative analysis of the relevant management policies of TCM preparations in medical institutions issued by the state, the strategy for the transformation of Chinese medicine preparations from medical institutions to new TCMs and the intellectual property issues existing in this process were put forward. Results and Conclusion: TCM preparations in medical institutions are a treasure trove of the research and development of new TCM. The policy documents recently issued in China, the active response of medical institutions, clear development ideas and scientific and standardized research will all contribute to the inheritance, development, and innovation of TCM preparations in medical institutions. |
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