Disputes about the research and development of syndrome traditional Chinese medicine(TCM) new drug in Guidance for syndrome TCM new drug development still exist, including the fact that it is unclear whether the compound TCM preparations just targeting a sort of syndrome is in line with the TCM theory and that it is obscure what are clinical advantages of syndrome new drug as compared with new drug targeting both disease and syndrome. Based on TCM classical theory, dating back to intervention opinions of successive dynasties, theory of three-dimensional N levels was proposed from the aspects of intervention modes, intervention latitudes and formulae to illustrate that the syndrome TCM new drug is in line with TCM theory. As for the first dimension, the intervention modes of TCM could be classified into targeting disease, targeting pathology and targeting symptoms, and the basic elements were extracted as constitution, disease, pathogenesis, pathology, location, symptoms, Western medicine pathology and Western medicine indicators. Among them, the mode targeting TCM constitution and the mode targeting pathology provided the theoretical possibility of TCM syndrome new drug, while the mode targeting disease was suitable for disease syndrome new drug. As for the second dimension, the intervention latitudes were summarized, including Yin-Yang, Qi-blood-body fluid, viscera, meridian, tri-jiao, Wei-Qi-Ying-blood, six channels, and local part. The relatively broad latitudes such as Yin-Yang, Qi-blood-body fluid, and meridian might be suitable for the development of TCM syndrome new drug. As for the third dimension, the TCM formulae could be divided into four types according to the range of indications, including broad indications, viscera pathogenesis indications, disease-targeting indications and symptom-targeting indications. The first two types were suitable for TCM syndrome new drug development, while the disease-targeting indication type fit for disease-syndrome new drug. According to theory of three dimensional N levels, the clinical orientation of syndrome TCM new drugs and their advantages over disease-syndrome new drugs were as follows: syndrome TCM new drugs may be considered for novel disease without clear basic pathogenesis or advance regulation, complicated diseases, complicating diseases, geriatric disease and ba-lancing TCM constitution.
Keywords: classics; research and development of new drug; syndrome Chinese medicine new drug; theoretical research.