中药新药研究的思路方法和实践

Thinking mode and practice of study on newly-developed drug of Chinese materia medica

中药新药研究涉及学科理论体系、研究对象、服务对象等多个主、客体系,是一个多因素的复杂的系统工程。对传统中医药学的朴素系统论、西医药学的近代还原论以及现代中医药学的现代系统论特征、优势和不足进行了归纳和辨析。从新药研究的系统思维的角度,将中药药物形成过程划分为药物原料形成、药物制备和药物体内过程3个基本环节,详细分析了各环节中诸影响因素。基于以上认识,提出了中药新药研究应遵循的思维模式和研究方法,并根据自己的科研实践,探讨了目前新药研究的热点及在研制过程中应注意的问题。最后提出:中药新药研究是一个系统工程,在思维模式上要从整体的视角、普遍联系和多变性的观点出发,以证实的实验手段和系统学的分析方法,从生命运动的不同层面,探索疾病的药物干预规律。秉承继承与创新相结合的原则,不断实现对传统中药的“扬弃”,从中“蜕变”出全新意义的现代中药。

To study the newly-developed drug of Chinese materia medica （CMM） for clinic use is an intricate systematical engineering with multi factors between subject and object, such as the theoretical system of disciplines, the objects of study, and the consumers of the drug. The characters, advantages, and deficiency in the simple systematic theory of traditional Chinese medicine （TCM）, the reductionism of the western medicine in the latter days, and the modern systematology of the neoteric TCM. Base on the view point of systematical thinking mode for study on new drug of CMM used for clinic, the forming process of CMM is divided into three stages, they are the formation of raw medicinal materials, the prepara- tion of the drug, and the in vivo metabolism of the drug, among every stages each factor is analyzed. The thinking mode and the research method explored for the newly-developed drug of CMM are put forward by the above-mentioned rational knowledge. The focuses and key problems in the study are approached in scientific practice. Finally an argument on this topic is set fourth. That is, applying the thinking mode to observing the interference rule of CMM on diseases in clinic from various sides of life movement in an integrity, common relation, and varied way by means of the verified experimental measure and systematic analysis method. Acting on the principle of combining the inheritance with the innovation, keeping on developing what is useful and healthy, and discarding what is not in TCM, the modern CMM will be degenerated and obtained in a completely new sense.