【摘要】 目的 了解注射用神经活素(nerve growth factor for injection，NGF)对大鼠的致畸胎性和胚胎毒性。方法 体重250～350g的Wistar大鼠分成5组，每组雄鼠15只、孕鼠30只，在妊娠D6～D15每天肌肉注射给药1次。NGF设40、200和1000u/kg 3个剂量组，分别相当于人临床拟用剂量的2.4、12和60倍。另设溶剂对照组和7mg/kg环磷酰胺阳性对照组。结果 注射用神经活素1000u/kg组胎鼠身长缩短，呈现一定胚胎毒性作用。40u/kg和200u/kg组及溶剂对照组的活胎率、吸收胎率、死胎率、外观畸形率、骨骼畸形率、内脏畸形率，胎鼠身长、尾长、体重等均在正常范围。环磷酰胺阳性对照组呈现阳性结果，提示所用动物种属对致畸物反应敏感，本次实验结果可靠。结论 未见明显母体毒性、胚胎毒性和致畸胎作用。

    【关键词】 注射用神经活素；胚胎毒性；母体毒性；致畸胎作用

    Teratologic studies of nerve growth factor injection in rats

    LI Hai-yan, WANG Ai-ping, ZHANG Qing-lin.

    Chinese Academy of Medicine Sciences and Peking Union Medical College,Beijing 100050,China

    【Abstract】 Objective Nerve growth factor for injection(NGF),a new drug used for peripheral nerve injury, was evaluated for its effects on reproduction, embryonal and fetal development.Methods Wistar rats weighting 250～300g were divided into five groups, each consisting of 15 males and 30 females. Doses of 0(control),40,200, and 1000u/kg body weight /day were given by muscle injection on days 6～15 of gestation, respectively. Fetuses were removed by cesarean section 1 day prior to expected parturition and were examined for external, skeletal, and/or soft tissue abnormalities, etc. A vehicle control was given at a volume equivalent to that administered to the highest drug dosage group and a positive control was given cyclophosphamide at a dose of 7mg/kg body weight.Results The occurrence of fetal length shorten in dosage group of 1000u/kg body weight appeared some embryotoxicity of nerve growth factor for injection. There are no major change which observed in dose of 0(control),40 and 200U/kg body weight such as viable fetuses rate , resorption and dead fetuses rate, external , skeletal , visceral abnormality, fetal weight and length, tail.Conclusion No evident matermal toxicity, embryotoxicity and teratogenicity resulted from nerve growth factor for injection(NGF). ......