To investigate the effects of Invigorating Spleen-Generating Blood Granule on embryo-fetal development of rats after intragastric administration. Methods: Pregnant rats were randomly divided into five groups: negative control, positive control, treatment groups with low, medium, or high dosage. The control groups were given oral administration with extract of the granule at 1.16、3.48、10.44 g/kg/d respectively for 10 days after six days pregnancy. The positive control group were given Vitamin A acetate at 0.08 g/kg/d； the negative group were given pure water with same volume. Then the weight, body length, food consumption, and clinical features of pregnant rats were recorded. Pregnant rats were dissected at their 20 days pregnancy. Then placentas, fetal rat appearances, skeleton, viscera, and numbers of corpus luteum, live fetus, dying fetus, absorbed fetus, implantation and other factors were recorded. Results: Obvious teratogenesis appeared in positive control rats, showed the reliability of the experiment. No abnormal clinical symptoms were observed in the rats of all treatment groups. There were no statistical differences of numbers of corpus luteum, live fetus, dying fetus, absorbed fetus, and implantation among the rats of all treatment groups and negative control. No general toxicity was found from rats with low or medium dosage. But high dosage of extract may result in a decline of weight, and food consumption. Furthermore, the development of fetal rats was also affected. Conclusion: The safe dosage of Invigorating Spleen-Generating Blood Granule on embryo-fetal development of rats was under 3.48 g/kg, 42 times of clinical dosage on human.