Min Zhang1, Xiaomeng Liu, Jie Song, Yanping Hu, Xiuwen Wang, Bo Li. 1. National Institute for Control of Pharmaceutical and Biological Products, National Center for Safety Evaluation of Drugs, Beijing 100176, China. zhangmin@nicpbp.org.cn
Abstract
OBJECTIVE: To investigate the potential developmental toxicity of Radix Ophiopogonis decoction in SD rats. METHOD: Timed-pregnant SD rats were given Radix Ophiopogonis decoction (26.9 g x kg(-1)) or vehicle (distilled water) by gavage on gestation days 6-17. Maternal clinical sign, abortions, premature deliveries, and body weight were monitored throughout gestation. At termination (gestation days 20) pregnant females were evaluated for clinical status and gestational outcome; live fetuses were examined for gender, external, visceral and skeletal malformation and variations. RESULT: No deaths, premature deliveries or dose-related clinical signs were attributed to Radix Ophiopogonis decoction. Maternal body weight and body weight gain were not affected. There were no effects on fetus weight and viability, incidences of fetal malformation and variation. CONCLUSION: These results demonstrated that Radix Ophiopogonis decoction had no detectable adverse effects in either the treated F0 female rats or the fetuses.
OBJECTIVE: To investigate the potential developmental toxicity of Radix Ophiopogonis decoction in SD rats. METHOD: Timed-pregnant SD rats were given Radix Ophiopogonis decoction (26.9 g x kg(-1)) or vehicle (distilled water) by gavage on gestation days 6-17. Maternal clinical sign, abortions, premature deliveries, and body weight were monitored throughout gestation. At termination (gestation days 20) pregnant females were evaluated for clinical status and gestational outcome; live fetuses were examined for gender, external, visceral and skeletal malformation and variations. RESULT: No deaths, premature deliveries or dose-related clinical signs were attributed to Radix Ophiopogonis decoction. Maternal body weight and body weight gain were not affected. There were no effects on fetus weight and viability, incidences of fetal malformation and variation. CONCLUSION: These results demonstrated that Radix Ophiopogonis decoction had no detectable adverse effects in either the treated F0 female rats or the fetuses.