神昌滴丸对孕鼠致畸性的研究

Study On teratogenicity of Shenchang-Drop Pill in Pregnant SD Rats

目的：评价神昌滴丸在妊娠期的毒性。方法：用80只孕鼠,分为3个不同的剂量（0.25、0.5、1.0g/kg）实验组,同时设阴性对照组（采用玉米油作为溶剂）,每组19-21只孕鼠。实验组和对照组给药容量为1mL/100g体重,均采用灌胃给药,给药时间为GD6-15。于妊娠第20天处死孕鼠,检查母体妊娠与胎鼠畸形情况。结果：神昌滴丸在1.0g/kg剂量出现母鼠增重下降,与对照组比较差异有统计学意义;各剂量组出现活胎率下降和死胎率增加,但与对照组比较有差异有统计学意义,不存在剂量反应关系;各剂量组的每窝平均活胎数和吸收胎率及致畸率与对照组比较差异无统计学意义。受试剂量下各组的平均胎盘重、胎儿体重、身长、尾长与对照组比较无统计学差异。低剂量组胸骨节数、骶椎数,高剂量组掌骨数与对照组相比差异具有统计学意义外（P〈0.05）,其它骨骼发育与对照组比较差异无统计学意义。各实验组均未观察到母鼠和胎鼠明显的外观、脏器以及骨骼的畸形。结论：神昌滴丸在1.0g/kg剂量时对孕期SD大鼠存在一定的母体毒性,在受试剂量下无明显的胚胎毒性、胎儿毒性和致畸作用。

Objective：To study the gestational toxicities of Shenchang-drop pill in SD rats during the period of organ formation.Methods： Eighty pregnant SD rats were randomly divided into four groups with about 20 rats in each,three Shenchang-drop pill dosage groups（0.25,0.5,1.0g/kg）,and one negative control group.Shenchang-drop pill and corn oil was given by intragastric administration to the treated groups and the negative control group for ten days during the period of organ formation（the 6th to 15th day of gestation）,respectively.The rats were sacrificed to examine the fetuses on the 20th day.Results：The results showed that Shenchang-drop pill produce significant difference on the body weight of pregnant rats under the administration of 1.0g/kg.Shenchang-drop pill may increase dead fetus ratio and decrease alive-fetuses ratio,but has no significant statistical difference on alive-fetuses ratio,embryonic resorption ratio and dead fetus ratio.There were no statistical difference on average weigh of placenta,crown-up length,length of fetuses tail and weight of fetuses.Except the number of sternal vertebra,sacral vertebrae and metacarpal bone,there were no statistical difference between treated groups and the negative control group.There is no found any teratogenic effect on the external,skeletal and internal organ examinations of the fetuses.Conclusion： Shenchang-drop pill has some effect on parent toxicity under the administration of 1.0g/kg,no teratogenic toxicity,no embryotoxicity and no fetotoxicity.