关键词: 中药物质映射, 中药0期临床试验, PD/PK, 曲面下体积, 全程质控标准体系

Abstract:

This paper proposed the concept of material mapping of traditional Chinese medicine (TCM), which is information or signals in a variety of media and biological effects of substances with drug effects that can be detected using existing techniques. Features of material mapping in different media can be qualitatively and quantitatively described using a three-dimensional map. Based on the material mapping,TCM development model is different from western medicine, which performs early phase (0 phases) clinical trials to obtain clinical efficacy information. PD/PK researches usually study the efficacy, yet the material of PK study does not necessarily have real effects, but a variety of components related to the efficacy. The in vivo exposure of the drug can be described by the VUC (volume under the curved surface). PD/PK study provides human evaluation criteria for subsequent formulation optimization studies. Quality control of TCM should cover the whole process from materials to the finished product, and qualitative & quantitative descriptions of material mapping are important components of quality control system. Before marketing, TCM should be validated by strict randomized and controlled clinical trials. The population selection and evaluation indexes may reflect the characteristics of TCM, but there is no difference of the logic reasoning of science between western medicine and TCM.

Key words: TCM material mapping, TCM phase 0 clinical trials, PD/PK, VUC, whole quality control system