Test Methods

In Vivo Test

Human studies are not available, the potential toxic effect of Chinese medicines for pregnancy should be evaluated in in vivo and/or in vitro models. For in vivo models, Chinese herbal medicines should be orally administered during pregnancy from pre-implantation period to post-implantation period. Adverse pregnancy outcomes were commonly observed after maternal exposure to the herbal medicines, particular during early pregnancy. Major events, including maternal and perinatal mortality, were recorded. Maternal weight gain, embryo growth, and postnatal weight gain were significantly decreased. Some reproductive toxicity, including fetal resorption, growth restriction, and congenital malformations were also identified.