癌变·畸变·突变 ›› 2002, Vol. 14 ›› Issue (3): 186-188.doi: 10.3969/j.issn.1004-616x.2002.03.014

• 检测研究 • 上一篇    下一篇

新药轻灵- 盐酸西部曲明的致畸试验

徐培渝, 王国钦, 刘玉清, 王正书, 庞定国   

  1. 四川大学华西医学中心毒理学教研室, 四川 成都 610041
  • 收稿日期:2001-11-22 修回日期:2002-03-07 出版日期:2002-07-30 发布日期:2002-07-30
  • 通讯作者: 徐培渝

STUDY ON THE TERATOGENICITY OF QINGLING2SIBUTRAMINE HYDROCHLORIDE IN RATS

XU Pei-yu, WANG Guo-qin, LIU Yu-qing, WANG Zheng-shu, PANG Ding-guo   

  1. Department of Toxicology, West China Medical Center, Sichuan University, Chengdu 610044, China
  • Received:2001-11-22 Revised:2002-03-07 Online:2002-07-30 Published:2002-07-30
  • Contact: XU Pei-yu

摘要: 目的为保证新药轻灵 盐酸西布曲明(Ql2sibutramine) 的临床用药安全,评价其生殖毒性,进行了大鼠致畸试验。方法:设3 个剂量组:0. 50 mg/ (kg·d) ,3. 16 mg/ (kg·d) 和20 mg/ (kg·d) ,最高剂量相当于临床拟用量的14. 8 倍,另设溶剂对照组和阳性对照组。于孕期6~15 d 经口给予受试物,检查对孕鼠和胎鼠的毒性和致畸性。结果:3 个轻灵2盐酸西布曲明剂量组均未诱发畸形,也不影响受精卵着床和胚胎存活,但中、高剂量组孕鼠呈现一定的毒性反应(摄食量减少和体重增长缓慢) ,胎鼠平均体重和身长也降低。结论:轻灵2盐酸西布曲明无致畸性,但有一定的母体毒性及发育毒性。

关键词: 轻灵-盐酸西布曲明(Ql-Sibutramine), 大鼠, 致畸试验

Abstract: Purpose : To assess the safety of Qingling2sibut ramine hydrochloride (Ql2sibut ramine) on the reproduction and development of rat s. Methods : The animals were divided into negative cont rol , positive cont rol and three experiment groups , and Ql2sibut ramine was administered by gavage during gestation day 7 to day 17 in doses of 0. 5 mg/ (kg·d) , 3. 16 mg/ (kg·d) and 200 mg/ (kg·d) , respectively. The body weight gain of pregnant rat s , the body weight , body length and tail length of living fetuses and some other parameters of embryonic development were measured. Results : Malformation of external and internal organ and of bone was not found in fetuses t reated with Ql2Sibut ramine. But the growth and food consumption of pregnant rat s were reduced during the exposure to the drug. The body weight and length of fetuses reduced also. Conclusion : Ql2sibut ramine does not induce deformity. But it is toxic to maternal rat s , and can cause growth retardation of fetuses in large dosage.

Key words: Qingling-sibut ramine hydrochloride, teratogenic effect, rat

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