›› 2012, Vol. 24 ›› Issue (1): 46-49.doi: 10.3969/j.issn.1004-616x.2012.01.011

• 论著 • 上一篇    下一篇

重组人B淋巴细胞刺激因子受体-抗体融合蛋白 (RCT-18)对大鼠的致畸作用

张立将，由振强，宋翼升，陈 颖，陈 浩，张丽丽，黄 敏，王文祥，房健民，宣尧仙   

  1. 1. 浙江省医学科学院安全性评价研究中心，国家浙江新药安全评价研究重点实验室，浙江 杭州 310053； 2. 烟台荣昌生物工程有限公司，山东 烟台 264006； 3. 同济大学生命科学与技术学院，上海 200092
  • 收稿日期:2011-04-15 修回日期:2011-05-25 出版日期:2012-01-30 发布日期:2012-01-30
  • 通讯作者: 宣尧仙

Teratogenicity and developmental toxicity of recombinant B lymphocyte stimulating factor receptor– antibody fusion protein (RCT-18) in rats

ZHANG Li-jiang，YOU Zhen-qiang，SONG Yi-sheng，CHEN Yin， CHEN Hao，ZHANG Li-li，HUANG Min，WANG Wen-xiang，FANG Jian-min，XUAN Yao-xian   

  1. 1. National Key Laboratory for Safety Evaluation of New Drugs, Center of Safety Evaluation, Zhejiang Academy of Medical Sciences, Hangzhou 310053, Zhejiang; 2. Rongchang Biotechnologies，Ltd., Yantai 264006, Shandong; 3. School of Life Science and Technology，Tongji University, Shanghai 200092, China
  • Received:2011-04-15 Revised:2011-05-25 Online:2012-01-30 Published:2012-01-30
  • Contact: XUAN Yao-xian

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摘要： 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。

关键词: 重组人B淋巴细胞刺激因子受体-抗体融合蛋白, 胚胎, 胎仔, 发育毒性, 致畸

Abstract: OBJECTIVE: To evaluate the teratogenicity and developmental toxicity of recombinant B lymphocyte stimulating factor antagonist–antibody fusion protein (RCT-18) in Sprague-Dawley (SD) rats. METHODS：Mated female rats were randomly segregated into four groups，including three RCT-18 groups (11，37 and 129 mg/kg) and one negative control group (sodium chloride injection)，with more than 25 rats in each group. RCT-18 was administered via subcutaneous injection to timed pregnant rats on gestation days (GD) 6-15 every two days. Clinical signs，body weights，and feed consumption were monitored during the whole gestation. Caesarean section and autopsy were performed on GD20. Uterine content were evaluated for number of implantations，resorptions，live and dead fetuses. The number of corpora lutea in each ovary was also recorded．Live fetuses were examined for gender，body weights，body lengths，tail lengths，and gross external，visceral and skeletal changes. RESULTS：There were no significant differences in maternal and embryo-fetal parameters. CONCLUSION：No maternal toxicity and embryo-fetal toxicities were found when RCT-18 was administered to SD rats during GD 6–15.

Key words: recombinant B lymphocyte stimulating factor antagonist – antibody fusion protein (RCT-18), teratogenicity, embryo, fetal, developmental toxicity

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