Abstract: OBJECTIVE To observe the embryotoxicity and teratogenicity of Xiaoruzeng capsule. METHODS Pregnant Wistar rats were randomly divided into five groups and each group had over 15 rats. Three dose groups rats(9.13, 4.55, 2.28 g?kg^-1) received intragastric administration during 7~16 d of gestation. All the pregnant rats were sacrificed on the pregnancy 20th day and measured number of corpus luteum, implantation, live embryo number, dead embryo and absorption embryo. To measure developmental condition and half of live embryo rats of each nest were dyed by the sodium alizarin sulfonate to inspect the whole body skeleton growth situation, and half of live embryo rats were given the internal organs inspection after the Bouin fluid immersion. RESULTS There was no statistically significant difference in weight of pregnant rats between all groups. Three dose groups and aspirin group’s number of absorbed fetus increased, live fetus and fetal length decreased significantly compared with blank group. There were significant differences on the skeletal malformations like defective ossification of the sternum. CONCLUSION The study shows that Xiaoruzeng capsule has significant embryo toxicity include embryonic death, growth inhibition and skeletal malformations.