摘 要
中药新药研发是中医药现代化的重要组成部分,而药效学评价在其中起着关键作用。随着现代科学技术的发展,传统中药药效学评价方法面临诸多挑战,亟需建立科学、系统且符合中药特点的评价体系。本研究旨在构建适用于中药新药研发的药效学评价方法,以提高中药新药研发效率与质量。通过文献分析、实验研究及多学科交叉融合,选取具有代表性的中药复方为研究对象,基于网络药理学、系统生物学等新兴技术手段,从整体观角度出发,构建了涵盖多靶点、多途径的药效评价模型。该模型不仅能够全面反映中药复杂体系的作用机制,还实现了对药物体内过程的动态监测。结果表明,所构建的评价方法能准确预测药效,为中药新药研发提供了可靠依据。创新性地将现代科学技术与传统中医药理论相结合,突破了以往单一成分评价模式,形成了一个综合性的评价体系,为中药新药研发中的药效学评价提供了新思路和新方法,有助于推动中药现代化进程。
关键词:中药新药研发;药效学评价;网络药理学;系统生物学;多靶点评价模型
Abstract
The development of new traditional Chinese medicine (TCM) drugs is an integral part of the modernization of TCM, with pharmacological evaluation playing a crucial role in this process. As modern science and technology advance, traditional TCM pharmacological evaluation methods face numerous challenges, necessitating the establishment of a scientific, systematic, and TCM-characteristic evaluation system. This study aims to construct a pharmacological evaluation method suitable for new TCM drug development to enhance the efficiency and quality of research. Through literature analysis, experimental studies, and interdisciplinary integration, representative TCM compound formulas were selected as research subjects. Leveraging emerging technologies such as network pharmacology and systems biology, a comprehensive pharmacological evaluation model encompassing multiple targets and pathways was constructed from a holistic perspective. This model not only fully reflects the complex mechanisms of action of TCM but also enables dynamic monitoring of the in vivo drug process. The results indicate that the constructed evaluation method can accurately predict pharmacological effects, providing a reliable basis for new TCM drug development. Innovatively integrating modern scientific technology with traditional TCM theory, this approach transcends the previous single-component evaluation model, forming a comprehensive evaluation system. This provides new ideas and methods for pharmacological evaluation in new TCM drug development, contributing to the modernization of TCM.
Keywords:New Chinese Medicine Drug Development;Pharmacodynamics Evaluation;Network Pharmacology;Systems Biology;Multi-target Evaluation Model
目 录
摘 要 I
Abstract II
引 言 1
第一章 中药新药研发的现状与挑战 2
1.1 中药新药研发的重要性 2
1.2 现行药效学评价体系局限 2
1.3 新药研发面临的科学问题 3
第二章 药效学评价方法的基本原理 4
2.1 药效学评价的核心要素 4
2.2 传统评价方法的特点分析 4
2.3 现代技术在评价中的应用 5
第三章 中药药效学评价的关键技术 6
3.1 指标体系的构建原则 6
3.2 生物标志物的选择策略 6
3.3 多层次评价模型的建立 7
第四章 药效学评价的质量控制体系 9
4.1 标准化的实验流程设计 9
4.2 数据处理与结果解读 9
4.3 评价体系的持续优化 10
结 论 12
参考文献 13
致 谢 14