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目的以受精大鼠和家兔为实验系统,评价牛蒡子苷元对动物胚胎-胎仔发育的影响,为其药用价值的进一步开发提供参考。方法 100只受精雌鼠分为溶媒对照组和牛蒡子苷元高、中、低剂量(64、16、4 mg/kg)组,每组25只;72只受精雌兔分为溶媒对照组和牛蒡子苷元高、中、低剂量(25、10、4 mg/kg)组,每组18只。全部动物于妊娠第6天(GD6)开始给药,每天ip给药1次,大鼠连续给药至GD15,停药至GD20解剖检查,家兔连续给药至GD18,停药至GD29解剖检查。试验期间,每天观察动物一般状态,定期检测动物体质量和摄食量,解剖时计数卵巢黄体数量、检查着床数和活胎数,测量活胎顶臀长和尾长,检查活胎外观、内脏和骨骼。结果给药期间,动物除给药方法导致的注射部位炎症反应外,其他未见异常体征变化;与溶媒对照组比较,牛蒡子苷元未引起大鼠和家兔体质量异常增长;母本动物受孕率、平均黄体数量和受精卵着床丢失率也未见异常改变;窝均活胎率、死胎率和吸收胎率,胎仔顶臀长和尾长也未见明显改变;也未见受试物导致的胎仔外观、内脏和骨骼畸形。结论牛蒡子苷元未见潜在的大鼠和家兔胚胎-胎仔发育毒性。在本试验条件下,牛蒡子苷元大鼠和家兔胚胎-胎仔发育毒性的无明显损害作用剂量(NOAEL)分别为64和25 mg/kg。
Objective To evaluate the effects of arctigenin on the development of fetal embryo and fetus by using fertilized rats and rabbits as experimental system and provide reference for the further development of medicinal value. Methods 100 fertilized female rats were divided into vehicle control group and arctigenin high, medium and low doses (64,16,4 mg / kg) group, 25 rats in each group; 72 fertilized female rabbits were divided into vehicle control group and Arctigenin was high, medium and low dose (25,10,4 mg / kg) group, 18 in each group. All animals were dosed on the sixth day of gestation (GD6) once a day for ip administration, rats were continuously administered to GD15, discontinued to GD20 for dissection, rabbits were given GD18 continuously, and discontinued to GD29 for dissection . During the test period, the general state of animals was observed daily. The body weight and food intake of animals were measured regularly. The number of corpus luteum was counted during the dissection. The number of implants and the number of live fetuses were examined. And bones. Results During the administration, the animals showed no signs of abnormal changes except for the inflammatory reaction at the injection site caused by the administration method. Compared with the vehicle control group, arctigenin did not cause abnormal growth of body weight in rats and rabbits; Pregnancy rate, average number of corpus luteum and implantation loss of fertilized eggs also showed no abnormal changes; litter size of live births, stillbirths and abdomen birth rate, fetal top hip length and tail length no significant change; nor the test Fetal appearance, visceral and skeletal deformities caused by the material. Conclusion Arctigenin has no potential embryonic-fetal developmental toxicity in rats and rabbits. Under the test conditions, the NOAEL of arctigenin-induced embryonic-fetal developmental toxicity in rats and rabbits were 64 and 25 mg / kg, respectively.