This project belongs to the field of clinical basic research in traditional Chinese medicine and integrated traditional Chinese and Western medicine. The main technological innovation content includes: Traditional Chinese medicine is widely used in China, but due to its complex composition, it can affect the activity of metabolic enzymes and transport proteins within the body. Its common combination with chemical drugs often leads to reduced therapeutic efficacy or increased toxicity when used together. Research on the interaction between traditional Chinese and Western medicines is therefore very necessary. We have established in vitro study techniques for drug-induced inhibition of drug metabolism enzymes using human liver microsomes and recombinant drug metabolizing enzymes; we have developed a technique for studying the induction of drug metabolism enzymes/transporters by drugs through primary human liver cell/CaCO2 cell culture and mRNA transcription measurement; and we have established a clinical research technique for studying the impact of traditional Chinese medicine on CYP activity using healthy volunteers and drug metabolism enzyme genotyping. Establish a detection technology for metabolic enzymes and metabolites in combination with traditional Chinese medicine multi-components using tandem mass spectrometry. Thus, based on the FDA's 'Guidelines for Drug-Drug Interaction Studies', a technical platform for studying the metabolic interactions between traditional Chinese and Western medicines has been established. This technical platform integrates drug analysis technology, cell molecular biology technology, and clinical medicine, combining experimental research on drugs with clinical research to achieve the transformation of traditional Chinese medicine experimental research into clinical medicine. Project Characteristics: This work is original in nature. The main characteristics include: (1) For the first time, an in vitro method using humanized cells was utilized to reveal the rationality and compatibility mechanism of the Zuojin Pill formulation from the perspective of metabolism/transport. (2) For the first time, healthy volunteers were used to discover that single-dose administration of Danshen Ketone Capsules has a differential effect on CYP3A inhibition, while long-term use induces CYP3A. Through in vitro methods with humanization, the components that inhibit CYP3A4 were identified as dihydrotanshinone I, and the inducing components were tanshinoneIIA and cryptotanshinone. The material basis for the differential effects on CYP3A was also clarified. (3) Clinical research on traditional Chinese medicine metabolic interactions using genotyping healthy volunteers found that Zuo Jin Wan has a regulatory effect on CYP2D6 activity, which can homogenize the enzyme activities of different CYP2D6 genotypes, providing direct guidance for clinical rational drug use. Research on the mechanism of TCM compound compatibility based on metabolism/transport was also carried out using technology for studying drug-drug interactions. By combining in vitro and in vivo studies, research on the impact of TCM on drug metabolizing enzymes/transporters was conducted and the material basis for its effects was tracked, providing evidence for the rational use of TCM in clinical practice and experimental support for the modernization of TCM. Application Promotion: Completed in vitro studies on the inhibitory effects of 28 traditional Chinese medicine (TCM) monomer components and 15 TCM preparations on CYP enzymes, as well as in vitro induction studies for 4 monomer components. Completed 4 human drug interaction studies with TCMs. Conducted a clinical study on new drug interactions by SFDA. Research results were published in international journals such as Drug Metabolism & Disposition, British Journal of Clinical Pharmacology, Xenobiotica, etc., with 7 SCI papers, 8 core Chinese journals, and 43 citations from SCI articles. Some research methods were incorporated into 'Research Methods in Traditional Chinese Medicine Pharmacology'. This technology platform has trained 3 young and middle-aged backbone personnel, 4 doctoral students, and 3 master's students. The technical platform has been applied to Shanghai University of Traditional Chinese Medicine, The Shanghai Institute of Materia Medica, Chinese Academy of Sciences, and the traditional Chinese medicine hospitals within the Shanghai Shenkang Hospital System provide services.