怀地黄提取物对大鼠的致畸性研究

目的 研究怀地黄提取物对无特定病源体(specific pathogen free, SPF)级SD (Sprague-Dawley)大鼠的胚胎毒性与致畸毒性。方法 受孕的雌鼠按体重随机分为5组: 怀地黄提取物低、中、高剂量组分别为0.5、2.0、8.0 g/(kg·BW)]、阴性对照组(等容量蒸馏水)和阳性对照组13 mg/(kg·BW)维生素A]。在受孕第6~15 d, 每天灌胃给予受试物, 试验期间记录大鼠孕期体重, 并于孕期第20 d处死母鼠, 剖腹取出子宫称量子宫连胎重, 检查并记录黄体数、活胎数、吸收胎数及死胎数。同时记录活胎仔的体长、体重, 检查活胎仔的外观、骨骼和内脏的发育情况。结果 怀地黄提取物各剂量组大鼠体重增重、胎鼠体重、胎鼠外观畸形率、胎鼠骨骼畸形率、胎鼠内脏畸形率均无显著性差异(P>0.05)。高剂量组胎鼠体长极显著降低(P<0.01), 下降率为1.4%, 无毒理学意义。低、中、高剂量组未观察到明显的孕鼠、胎鼠毒性, 未发现致畸作用。结论 在本研究条件下, 未发现怀地黄对SD大鼠的母体毒性、胚胎毒性和致畸毒性。

Study on teratogenicity of Rehmannia glutinosa extract in rats

Objective To investigate the embryo toxicity and teratogenic toxicity of Rehmannia glutinosa extract in specific pathogen free (SPF) grade SD (Sprague-Dawley) rats. Methods The pregnant female rats were randomly divided into 5 groups according to body weight: Low-dose, medium-dose and high-dose groups 0.5, 2.0, 8.0 g/(kg·BW)] of Rehmannia glutinosa extract, negative control group (constant volume distilled water) and positive control group 13 mg/(kg·BW) vitamin A]. On the 6th to 15th day of pregnancy, the pregnant rats were given Rehmannia glutinosa extract every day, the weights of the rats were recorded during the experiment, and the female rats were killed on the 20th day of pregnancy, the uterus was taken out to weigh the uterus and fetus, and the numbers of corpus, live births, absorbed fetuses and stillbirths were examined and recorded. At the same time, the body lengths and body weights of live foetus were recorded, and the appearance, bone and visceral development of live fetus were examined. Results There was no significant difference in weight gains of rats, weight of fetal rats, appearance deformity rates of fetal rats, bone deformity rates of fetal rats, and visceral deformity rates of fetal rats in each dose of Rehmannia glutinosa extract group (P>0.05). There were significant differences in fetal body lengths in the high-dose group (P<0.01), but the decrease rate was 1.4%, which had no toxicological significance. No significant toxicity was observed in the low, medium and high dose groups in pregnant rats and fetal rats, and no teratogenic effects were found. Conclusion The maternal toxicity, embryo toxicity and teratogenic toxicity in SD rats are not found under the experimental conditions.