以功效为基础的中药复方毒性研究思路与方法探索

Research Thoughts and Approaches of Toxicity Based on Efficacy of Chinese Herbal Compound

中药复方的毒性研究是目前复方研究的关键问题之一。在回顾中医传统理论对中药毒性认识的基础上,结合中药复方配伍理论,认为中药复方的毒性是在中医理论指导下对其功效及相关药理作用的反面认识,随机体的状态而发生变化。因此复方整体的功效与毒性之间存在相互依存、相互转化的关系。以功效为基础的中药复方毒性现代研究,将更好地阐释传统中药复方功效和毒性理论,为中药复方的临床安全、合理应用提供科学依据。目前的中医证候模型研究尚存在一些不足,如造模方法不一致、评价指标不统一等,使模型的引用受到限制,与功效相关的中药复方评价不充分,需建立一个体现功效的中药复方毒性评价体系,在这个体系当中以现代中药复方的急、慢性毒理学研究为基础,通过病证结合动物模型的研究,以复方功效为核心,采用方证相应和方证背离的研究思路进行中药复方的药效以及副作用评价,同时应借鉴药代动力学、药理学、代谢组学等学科技术,以观察中药复方作用于机体后的生物学效应及其内在作用机制,进而阐述清楚中药复方毒性的实质内涵。

The toxically study of Chinese herbal compound is one of key problems in traditional Chinese medicine （TCM）. By reviewing toxicity of Chinese herb in TCM theory and drug matching theory in Chinese herbal compound, this paper considers that toxicity of Chinese herbal compound is adverse side of its efficacy and pharmacological function under the guide of Chinese medicine theory, and it also changes along with physical states. Thus the relation of mutual dependence and transformation always exists between efficacy and toxicity of Chinese herbal compound. By modern research of efficacy of Chinese herbal compound, the efficacy and toxicity theory of Chinese herbal compound will be better elucidation, which can provide scientific evidence for the rational and safe use of Chinese herbal compound in clinic.