本文强调了设计与中药新药质量的密切关系。作者认为应以中药药性理论为指导,例如四气（寒、热、温、凉）五味（辛、甘、酸、苦、咸）、升降浮沉、归经和毒性,从临床方入手进行方药筛选,结合药物理化性质和药效结论,精简药味;其次应在粉碎、提取、分离等方面引用新技术,选择合理剂型,优化工艺。

This article emphasizes the close relationship between the design and quality of new drugs of traditional Chinese medicine （TCM）. The author holds that firstly, the selection of Chinese medicinal materials in a prescription should be under the guidance of the theories of their properties, such as the four qi （cold, heat, warmth and coolness） and five tastes （pungency, sweetness, sourness, bitterness and saltness）; the ascending, descending, floating and sinking of pulse; and the meridian distribution and toxicity of medicinal materials, in accordance with clinical diagnosis and the medicinal materials in a prescription should be simplified in combination with the judgement of their physicochemical properties and effectiveness, and secondly, new technologies for the smashing, extracting and isolating of medicinal materials should be introduced and appropriate forms of drugs be taken so as to optimize their technical processes.

国家中医药管理局国家中医药新药开发专项课题(DIX034A)