Abstract: Purpose : To assess the safety of Qingling2sibut ramine hydrochloride (Ql2sibut ramine) on the reproduction and development of rat s. Methods : The animals were divided into negative cont rol , positive cont rol and three experiment groups , and Ql2sibut ramine was administered by gavage during gestation day 7 to day 17 in doses of 0. 5 mg/ (kg·d) , 3. 16 mg/ (kg·d) and 200 mg/ (kg·d) , respectively. The body weight gain of pregnant rat s , the body weight , body length and tail length of living fetuses and some other parameters of embryonic development were measured. Results : Malformation of external and internal organ and of bone was not found in fetuses t reated with Ql2Sibut ramine. But the growth and food consumption of pregnant rat s were reduced during the exposure to the drug. The body weight and length of fetuses reduced also. Conclusion : Ql2sibut ramine does not induce deformity. But it is toxic to maternal rat s , and can cause growth retardation of fetuses in large dosage.

Key words: Qingling-sibut ramine hydrochloride, teratogenic effect, rat