中药安全性问题受到广泛重视，然而由于中药成分复杂，使寻找中药毒性成分是一个普遍的难题。传统的分离各成分、然后进行整体动物实验评价的方法，以及体外细胞实验高通量筛选的方法都有其固有的缺点。.本项目在“血清药理学，中药血清药物化学和靶器官毒理学”的基础上，根据靶器官药物浓度变化趋势常与血液中并不相同的现象，提出“基于靶器官效应和分布的毒效筛选方法”，使用靶器官药物动力学参数对体外实验结果进行校正，并引入类似于药物“治疗指数”的指标，用安全指数S=T/E评价中药成分的相对安全性。旨在建立一种简单、可行、准确的中药毒性成分筛选方法，为中药安全性和毒性物质基础研究提供新思路。结合补骨脂中各成分对靶器官效应（毒-效）和分布情况，使用新本方法对补骨脂中至少20个成分进行毒效评价，选择最少6个成分进行体内实验评价来验证方法的可行性，阐明补骨脂的毒效物质基础，为补骨脂减毒和含补骨脂的中成药二次开发提供支持。

The safety of traditional Chinese medicine (TCM) has attracted many interests from researchers. But since the composition of traditional Chinese medicine is very complex, screening and identifying toxic ingredients from TCM is usually difficult. The techniques of high throughput screen in vitro and the method of extracting and isolating monomer composition from traditional chinese medicine then tested in vivo are both far from impeccable..The project was base on “serum pharmacology and serum pharmacochemistry and target organ toxicology”. Drug concentration in target organ often differs from that in blood. Therefore, we propose a screening method according to the effects and distribution of drugs in the target organ. It uses drug kinetic parameters of target organ to correct experimental results in vitro. And the safety index (S=T/E), which is similar to the therapeutic index, was used to evaluate the relative safety of various ingredients. The aim of this project is to establish a simple feasible and accurate method of screening toxic ingredients in TCM and provide a new idea about safety and toxic substances of TCM. With effects and distribution of the components in Fructus Psoraleae, at least 20 components from Fructus Psoraleae Psoralea corylifolia will be evaluated of their toxicity and efficacy using this new method. And at least 6 components will be evaluated in vivo. Identifying toxic components in Fructus Psoraleae would support studies to reducetoxicity of Fructus Psoraleae and guide improvement of Chinese medicine formula containing Fructus Psoraleae.