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2024, 04, v.47 803-809
现代中药制剂创新研发模式“证-药-方-剂”的构建
基金项目(Foundation): 国家自然科学基金项目(82004075); 西安医学院科研能力提升计划项目(2022NLTS059,2022NLTS062);西安医学院科技创新团队配套项目(2021TDPT04); 扬中市第十批“江雁计划”人才项目(扬人才办[2021]26号)
邮箱(Email):
DOI: 10.13863/j.issn1001-4454.2024.04.001
摘要:

中医药是中国医疗体系的重要组成部分,并为人民的生命健康做出了重要贡献。然而近代以来,随着科学技术的发展、生态环境的演变、人们生活工作方式的变化与人类疾病谱及病因发生了较大的更迭,因此,中医药创新发展面临重大挑战与机遇。目前,对于中药现代化的本质以及现代科技如何融入中医药尚无统一认识,造成临床疗效低于预期是中医药临床推广与应用面临的困局,也是中医药创新发展的核心“卡脖子”问题。如何传承、创新与发展中医药,进一步提高其临床疗效和工业化水平以满足疾病救治需求,是现代中药制剂创新研发的关键。本论述基于多年中药新产品研发、转化与临床应用实践,构建了“证-药-方-剂”的现代中药制剂创新研发模式,将中医药理论与现代疾病病机、中药药理机制和药效物质以及新型制剂技术等有效融合,通过“证-药-方”解决中药临床疗效的问题,通过“剂”解决中药制剂的工业化水平与患者用药的便捷性问题,从而为以临床治疗为目的现代中药制剂创新研发提供了模式借鉴。

Abstract:

The traditional Chinese medicine(TCM) is an important part of China′s medical system and has made important contributions to the life and health of people.However, in the period of the new era, with the development of modern science and technology, the evolution of ecological environment, the change of people′s lifestyle and work style, and the changes of human disease spectrum and etiology, the innovation and development of TCM are facing major challenges and opportunities.At present, there is no unified understanding of the essence of TCM modernization and how the modern technology can be integrated into is integrated into TCM.This caused the clinical efficacy is lower than expected is the bottleneck of the clinical promotion and application of TCM,and also the key troublesome issue on the innovation and development of TCM that urgently needs to be solved.Then, how to inherit, innovate and develop TCM to solve the problem of improving its clinical efficacy is the key to the research and development of modern TCM preparations.Based on the research and development, transformation and clinical application of new TCM products for many years by the author′s research group, this paper constructed an innovative research and development model of "syndrome-medicine-prescription-preparation" for the modern TCM preparations.And the theory of TCM is effectively integrated with modern disease pathogenesis, pharmacological mechanism and effective substances of TCM,as well as new preparation technology.Then the problem of clinical efficacy of resolved by "syndrome-medicine-prescription",the industrialization level and convenience of medication for patients of TCM resolved by "preparation",thus providing model reference for innovative research and development of modern TCM preparations with high clinical treatment value.

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基本信息:

DOI:10.13863/j.issn1001-4454.2024.04.001

中图分类号:R288

引用信息:

[1]李伟泽,赵宁,韩文霞等.现代中药制剂创新研发模式“证-药-方-剂”的构建[J].中药材,2024,47(04):803-809.DOI:10.13863/j.issn1001-4454.2024.04.001.

基金信息:

国家自然科学基金项目(82004075); 西安医学院科研能力提升计划项目(2022NLTS059,2022NLTS062);西安医学院科技创新团队配套项目(2021TDPT04); 扬中市第十批“江雁计划”人才项目(扬人才办[2021]26号)

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