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目的:观察重组人B淋巴细胞刺激因子受体-抗体融合蛋白(RCT-18)对大鼠胚胎及胎仔的发育毒性和致畸作用。方法:采用雌性SD大鼠,交配成功后随机分为4组,即RCT-18高(129 mg/kg)、中(37 mg/kg)、低(11 mg/kg)剂量组及阴性对照(0.9%NaCl注射液)组,每组≥25只,于妊娠第6～15天连续5次(隔天1次)经皮下注射给药。实验过程中观察动物的一般反应、体质量、摄食量变化,于妊娠第20天解剖孕鼠,对着床、吸收胎、死胎、活胎、黄体进行计数,对胎仔的体质量、身长、尾长,以及外观形态、内脏和骨骼发育等指标进行评价。结果:孕鼠、胚胎形成、胎仔生长发育、外观形态、内脏和骨骼发育等各项指标均无明显异常,与阴性对照组比较无明显毒性影响(P>0.05)。结论:在本试验条件下,RCT-18对SD大鼠未见明显母体毒性和胚胎-胎仔发育毒性,无致畸作用。
Objective: To observe the developmental toxicity and teratogenic effects of recombinant human B lymphocyte stimulating factor receptor-antibody fusion protein (RCT-18) on embryonic and fetal rat embryos. Methods: Female Sprague-Dawley rats were randomly divided into 4 groups: RCT-18 high (129 mg / kg), medium (37 mg / kg) and low (11 mg / kg) 0.9% NaCl injection) group, each group with ≥25, administered subcutaneously 5 times (once every other day) on the 6th to 15th day of gestation. During the experiment, the general reaction, body weight and food intake of animals were observed. The pregnant rats were dissected on the 20th day of gestation. The pregnant rats were implanted on the bed, aborted fetus, stillbirth, live fetus and corpus luteum. The body weight, Length, shape and appearance, visceral and skeletal development and other indicators were evaluated. Results: Pregnant mice, embryo formation, fetal growth and development, appearance morphology, visceral and skeletal development and other indicators were not abnormal, with no significant toxic effects compared with the negative control group (P> 0.05). Conclusion: Under the experimental conditions, no obvious maternal toxicity and embryo-fetal development toxicity of RCT-18 on SD rats, no teratogenic effect.