蒲地蓝消炎口服液虽非为儿童专用中成药，近年来被儿科临床广泛应用，而且其清热解毒、消肿利咽功效的物质基础和作用机制还仍不十分明确。故如何建立一个科学有效的系统研究模式并科学地阐述其物质基础和作用机理，迫切为蒲地蓝消炎口服液的儿童临床用药安全提供支撑研究。本项目拟以解热抗炎作用为切入点展开研究，在其体外指纹图谱分析的基础上应用网络药理学与分子对接技术筛选活性成分与潜在靶标；进一步通过血清药物化学、血清药理学、药代动力学与代谢组学确定功效标志物、表征功效的生物标志物与表征过度治疗的预警生物标志物；在此基础上进行分子水平上的细胞生物学的研究，推断并验证与解热抗炎作用的相关通路，从而实现从整体动物水平到微观分子水平构建基于“功效标志物-生物标志物-靶标通路”关联模式的中药功效物质基础与作用机制研究。本研究是多学科研究方法、理论与技术的融合性创新，为中药物质基础及作用机理研究提供新的研究思路与借鉴。

Pudilan Xiaoyan Oral Liquid is not a Chinese patent medicine for children, it has been widely used in pediatric clinics in recent years, and the material basis and mechanism of clearing heat and detoxification, detumescence and liyan effects are still not very clear. Therefore, how to establish a scientific and effective systematic research model and scientifically explain its material basis and action mechanism, urgently provide support research for the safety of Pudilan Xiaoyan oral liquid in children’s clinical medicine. This project intends to carry out research based on the antipyretic and anti-inflammatory effects, apply network pharmacology and molecular docking technology to screen active ingredients and potential targets on the basis of fingerprint analysis of Pudilan Xiaoyan oral liquid, and further get the efficacy markers, biomarkers characterizing efficacy and early warning biomarkers characterizing overtreatment through serum medicinal chemistry, serum pharmacology, pharmacokinetics and metabolomics, then the relevant pathways of antipyretic and anti-inflammatory effects are inferred and verified through the molecular level of cell biology research. Thus, the material basis and action mechanism based on the “Efficacy marker – Biomarker - Target pathway” correlation mode can be constructed from the overall animal level to the microscopic molecular level. This research is a fusion innovation of multi-disciplinary research methods, theories and technologies. It provides new research ideas and references for the research on the material basis and action mechanism of traditional Chinese medicine.