中药新药的研究与开发是复杂的系统工程,处方配伍及组方用药是新药研究的起始,是决定主治功效及相关实验研究的前提。本文分别从依据中医药理论与临床辨治用药经验:结合现代病因病理认识及中药药效学研究成果;应用的民间药材、少数民族药材、及其新的药物资源;以中药材、天然药物中提取的有效成分、有效部位、有效提取物等方面,组成中药新药制剂。依据中西医药理论与实验研究成果,组成中西药结合新制剂;运用天然药物化学研究的生物活性先导物,进行结构改造或修饰以及类似物合成,研制新制剂;通过中药各种成分与金属离子的络合作用,形成新的络合物,研制中药新制剂等方面,阐述了中药新药研究中的处方来源、组方用药及相关问题的思路。

The study and development of new Chinese medicines are a complex systematic engineering. The prescription and compatibility and the formulating of prescription of traditional Chinese medicine mark the beginning of the study of new Chinese medicines and the pre - requisites that determine the major functions and related experiments and studies of new medicines. This article explores how to make up preparations of new Chinese medicines in accordance with the theories of traditional Chinese medicine and clinical experiences of treatment based on patients' illnesses and condition in combination with the knowledge of modern etiology and pathology and the research achievements from the pharmacodynamics of traditional Chinese medicine and by making use of folk medicinal materials and the medicinal materials of national minorities and their newly - emerging medicinal materials, as well as the effective constituents, total effective components and other effective extracts of Chinese medicinal materials and natural medicinal plants; how to compose new preparations with the combination of Chinese and Western medicine according to the theories of Chinese and Western medicine and the achievements from studies and experiments; how to develop new preparations of Chinese medicines by the application of bio - active guides from the study of modern natural pharmaceutical chemistry to remould or modify the structure of medicinal materials, as well as similar compounds; and how to develop new preparations of Chinese medicines through the complexing action of various elements of Chinese medicinal materials and metal ions to form new complexes. The sources of prescriptions, the formulating medicinal materials in prescriptions and other relevant problems are also expounded in the article.