复方血栓通胶囊上市后质量与药效再评价研究进展

Fufang Xueshuantong Capsule (FXC) is a traditional Chinese medicine (TCM) formula composed of four herbs including Notoginseng Radix et Rhizoma, Astragali Radix, Salviae Miltiorrhizae Radix et Rhizoma, and Scrophularize Radix. Long-term, extensive clinical applications have confirmed that FXC could exert significant effects on fundus vascular diseases and stable angina pectoris. This review aims to systematically analyze and summarize the existing researches involving quality and efficacy re-evaluation of FXC, point out the typical problems, and further propose some opinions to contribute to future study. As a result, this review outlines the chemical profiles, quality control, pharmacokinetic and pharmacological properties of FXC based on reported results. Some problems are pointed out for FXC: the quality control needs further improvement, the pharmacokinetic properties have not been comprehensively investigated, and in-depth and systematic mechanism researches are scarce. Hereon we propose several directions for future study: (a) establishment of feasible HPLC or LC-MS based quantitative methods for simultaneous determination of multiple components to monitor the overall quality; (b) pharmacokinetic studies concerning humans, drug-drug interactions, and correlation with pharmacodynamics; (c) pharmacological mechanism researches integrating multi-omics technologies (gut microbiome, metabolomics, etc.).