选题和科研设计是新药研究的两个关键环节,中药新药研究面对的是一个多维、多重的复杂体系,因此,选题和科研设计尤为重要。本文系统分析了中药及健康相关产品的市场因素, 提出中药新药的选题原则和思路;根据中药研究所涉及的基原、药材采集、加工、炮制、组方、制剂、药效及安全性评价等环节的多样性、复杂性和变化性以及之间的紧密联系,提出中药新药科研设计和试验实施的系统思维。

The selection of research subjects and the design of scientific research on the subjects are two of key links in the study of new drugs, and they are even more important in the study of new drugs in traditional Chinese medicine since such a study faces a complicated system of multi - division and multiplicity. This article systematically analyzes the marketing factors of Chinese medicine and its relevant products in health care; proposes principles and ideas for the selection of research subjects in TCM; and advances the systematic thinking concerning the design of scientific research and the implementation of experiments of new drugs in TCM in accordance with the diversity, complexity and variability of such links as the origin, collection, processing and preparation of medicinal materials; the formulation of prescriptions; and the assessment of the preparations, effectiveness and safety of drugs, which are referred to in the study of Chinese medicine, as well as the close relationship among them.