首页|古代经典名方中药复方制剂的转化研究与审评决策思路

古代经典名方中药复方制剂的转化研究与审评决策思路

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古代经典名方是历代医家临床经验的总结，做好古代经典名方中药复方制剂的研究转化，对于中药传承创新发展意义重大。近年中医药在新型冠状病毒肺炎大流行防治过程中的及时性、可及性、可负担性，也凸显了加快古代经典名方新药转化的重要性。古代经典名方中药复方制剂的研发依据是因为其"至今仍广泛应用、疗效确切、具有明显特色与优势"，其安全性和有效性得到长期使用验证，因此与以往的中药复方制剂新药的研发模式、逻辑和技术要求存在差异。本文通过对中药复方制剂研发模式的思考，对古代经典名方中药复方制剂的提出与实践、研发审评逻辑与技术要求等进行了分析，并结合研发和审评实际进行了思考和讨论，以期为古代经典名方复方制剂研发提供参考。
Translational Research and Review Decision Strategy of TCM Compound Preparations Based on Ancient Classical Prescriptions
Ancient classical prescriptions(ACPs)are the summary of clinical experience of doctors in the past dynasties.The research on transla-ting ACPs into TCM compound preparations is of great significance for the inheritance,innovation,and development of TCM.The timeliness,accessibility,and affordability of TCM in the prevention and treatment of CO VID-19 have emphasized the importance of accelerating the trans-lational research on ACPs.The research and development(R&D)of ACPs are based on the wide application,definite efficacy,and unique characteristics and advantages of ACPs.The safety and efficacy of ACPs have been verified by the long-term use in humans.Therefore,the mode,logic,and technical requirement of the R&D of TCM compound preparations based on ACPs are different from those of previous TCM compound preparations.By reflecting on the R&D mode of TCM compound preparations,this paper introduces the proposal,practice,review logic,and technical requirements in the R&D of TCM compound preparations based on ACPs,and puts forward suggestions with consideration to the R&D and review practices,aiming to provide reference for the R&D of TCM compound preparations based on ACPs.

Ancient classical prescriptions(ACPs)TCM compound preparations based on ACPsResearch and development modeTech-nical requirementsTCM regulatory science

宋菊、阳长明、于江泳、韩炜、曲建博、赵军宁

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国家药品监督管理局药品审评中心,北京 100076

国家药品监督管理局,北京 100037

古代经典名方 古代经典名方中药复方制剂 研发模式 技术要求 中药监管科学

国家药监局中国药品监管科学行动计划药品监管科学全国重点实验室课题(第一批)(2023)

国药监科外[2019]23号

2024

中药药理与临床
中国药理学会 四川省中医药科学院

中药药理与临床

北大核心
影响因子：0.996
ISSN：1001-859X
年,卷(期)：2024.40(3)
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