The quality of traditional Chinese medicine (TCM) is the significant bottleneck for the development of TCM modernization. TCM quality control like fingerprint, which based on chemical analysis has limits such as the unknown active components and the inconsistence between chemical components and activity. Therefore, new bioactivity evaluation-based quality control method is of great necessary. Based upon the long-term accumulation of clinical experiences and pharmacological mechanism research of Fuzheng Huayu (FZHY) in our research group, as well as the significant demand in international clinical trials, we hereby propose the following scientific hypothesis: FZHY has the major pharmacological targets for anti-hepatic fibrosis. The FZHY influence on transcriptional activity of those pharmacological targets, ?may reflect its anti-hepatic fibrosis effect well. Firstly, four cell lines, hepatic stellate cell, hepatic endothelial cell, hepatic cell and macrophage are selected to investigate the cell effect influenced by solvent, working concentration and time, so that a standard in-vitro drug delivery system will be optimized and established. Secondly, we try to discover the key pharmacological target of FZHY on liver fibrosis in terms of cell signaling pathway, protein chip and network pharmacology. And finally, recombinant reporter gene plasmid containing target gene promoter and stably transfected cell lines will be established and different batches of FZHY will be evaluated and compared on target gene transcription activity, cell bioactivity and anti-hepatic fibrosis effect in animal model. Meanwhile, components of FZHY will be analyzed as well. The purpose is to establish a new bioactivity evaluation-based quality control method for anti-hepatic fibrosis TCM, to provide new technical platform for the improvement of TCM quality and the discovery of novel drug.