孕妇是流感高发、重症及死亡的高危人群，其妊娠期用药的安全性是临床面临的棘手问题。双黄连可抑制多种流感病毒的有效性已得到证实，课题组前期应用EST实验评价双黄连胚胎蓄积组分黄芩苷为弱胚胎毒性。鉴于：①妊娠期胎儿所需的营养物质均来源于胎盘，②中药组分复杂，成分间相互作用难以预测，仅考察单一组分的胚胎毒性不能全面评价其安全性，③种属差异使动物实验结果难以直接外推到人类。因此，以胎儿体内药物成分为受试物得到的胚胎毒性预测才能准确评价药物的安全性。本课题拟①建立人胎盘屏障体外模型，获得透过胎盘屏障进入胎儿体内的药物成分作为受试物进行EST，评价双黄连的胚胎毒性。②应用人离体子宫平滑肌实验观察双黄连对子宫平滑肌的影响。③应用HPLC-MS技术分析胎儿体内药物成分，明确双黄连胎儿宫内暴露的物质基础。科学地评价孕期应用双黄连的安全性，并为妊娠期应用中药的安全性评价提供一套符合中医药特点的系统的研究方法

Gestational women are in high risk and high incidence of severe and fatal cases of influenza.The medication safety during pregnancy is a tough problem faced by physicians. Shuanghuanglian inhibit the influenza virus has been confirmed, our previous study suggested that Baicalin which is embryonic accumulated component from Shuanghuanglian has showed weak embryotoxicity by embryonic stem cell test（EST）. View of: ① The nutrients required by fetus are derived from the placenta. ② The Chinese medicine components are complex, it is difficult to predict the interaction between components, and single component embryotoxicity investigation can not be used to evaluate the safety totally.③ Due to species differences, the results of animal experimental are difficult to be applied to human. Therefore, the Chinese medicine components through the placental barrier should be the test substance to evaluate the drug embryonictoxicity. The purpose of this study: ① Establish model of human placental barrier in vitro, obtain the components through the placental barrier as a test substance, and evaluate Shuanghuanglian embryotoxicity by EST. ② Observe the effect of Shuanghuanglian on smooth muscle uterine in vitro. ③ Analyze the Chinese medicine components in fetus by HPLC-MS to clarify the fetal intrauterine exposure of Shuanghuanglian. We intend to evaluate the Shuanghuanglian's drug safety, and provide a set of system to evaluate the application of Chinese medicine safety during pregnancy with Chinese medicine characteristics.