中药药效物质与临床疗效和中药质量密切相关，探索中药的化学物质与机体生命活动的交互规律，是揭示中药治疗疾病的原理、阐明中药药效物质的基本途径。前期研究发现小叶莲提取物具有较强的抗乳腺癌作用，其乙酸乙酯萃取部分为抗乳腺癌有效部位。为了阐明小叶莲抗乳腺癌药效物质，本研究拟运用中药药理学、中药分析、中药化学、中药药代动力学多学科交叉的方法，以移植性和药物诱发性乳腺癌动物为模型进行药效学研究，同时采用液质联用技术研究小叶莲原形成分及代谢产物的体内动态分布特征，通过对生物样品指纹谱和效应之间的关系进行分析，结合在线活性检测，推测潜在药效成分，然后在LC-MS的引导下，对潜在的药效成分进行分离制备，并通过体内、体外实验进行活性验证。最终阐明小叶莲有效部位在乳腺癌模型动物体内的药效学、药动学特征和抗乳腺癌的药效物质。本项目将为中药药效物质研究提供思路，对指导中药的质量控制和临床应用具有重要意义。

The therapeutic effect and quality of traditional Chinese medicine (TCM) are known to directly depend on its effective substances. It is the basic way to reveal the principle of TCM to treat diseases and clarify the effective substance of traditional Chinese medicine by exploring the interaction between the chemical substances and the organism's life activities. In previous studies, we have found that the extract of the Sinopodophylli Fructus has a strong anti breast cancer effect, and its ethyl acetate soluble fraction is the effective part of anti breast cancer. In this program, we will do research in a multi-disciplinary manner by using the methods of pharmacology, TCM analysis, chemistry, and pharmacokinetics. Firstly, we will apply Sinopodophylli Fructus to treat the animals with breast-cancer, and study its in vivo process in the animals simultaneously by LC-MS. Secondly, the potential effective substances of Sinopodophylli Fructus will be proposed by analyzing the relationship between the fingerprints of biosamples and the efficacies of Sinopodophylli Fructus, combined with on-line activity detection. Thirdly, the potential effective substances will be isolated and prepared from Xiaoyelian or biosamples guided by LC-MS. Finally, the pharmacological effects of potential effective substances will be verified by in vitro and in vivo models. This program will not only clarify the in vivo process of Sinopodophylli Fructus in animals with breast cancer, but also clarify the effective substances of anti breast cancer. Furthermore, this program will provide ideas for the research on effective substances of TCM, and to the quality control and clinical application of traditional Chinese medicine has important guiding significance.