Yanagi H, Yamaguchi K, Shimizu K, Shichino Y, Nishiyama K, Mori H, Shinomiya K, Ueda H, Suzuki Y, Oida H, Nishibata K, Tanaka M, Yonezawa H, Fujita T
Fukui Institute for Safety Research, ONO Pharmaceutical Co., Ltd., Japan.
J Toxicol Sci. 1998 Jul;23 Suppl 3:415-34. doi: 10.2131/jts.23.supplementiii_415.
A 4-week repeated dose toxicity study with 4-week recovery test of sodium N-[2-[4-(2,2-dimethylpropionyloxy) phenylsulfonylamino] benzoyl] aminoacetate tetrahydrate (ONO-5046.Na), a novel neutrophil elastase inhibitor, was conducted in Sprague-Dawley (SD) rats. The rats of both sexes were administered ONO-5046.Na intravenously at a daily dose of 0 (vehicle control and saline control), 18.75, 37.5, 75 or 150 mg/kg. ONO-5046.Na did not affect signs, body weight, food consumption, ophthalmology, urinalysis, hematology, blood chemistry, organ weights, necropsy or histopathology at any dose. These results indicate that the NOAEL of (ONO-5046.Na in rats is 150 mg/kg/day for both sexes in this study.
对新型中性粒细胞弹性蛋白酶抑制剂N-[2-[4-(2,2-二甲基丙酰氧基)苯磺酰氨基]苯甲酰]氨基乙酸钠四水合物（ONO-5046.Na）进行了为期4周的重复剂量毒性研究，并进行了为期4周的恢复试验，实验对象为Sprague-Dawley（SD）大鼠。对雌雄大鼠静脉注射ONO-5046.Na，日剂量分别为0（溶剂对照组和生理盐水对照组）、18.75、37.5、75或150mg/kg。在任何剂量下，ONO-5046.Na均未影响大鼠的体征、体重、食物消耗量、眼科检查、尿液分析、血液学、血液生化、器官重量、尸检或组织病理学结果。这些结果表明，在本研究中，ONO-5046.Na对雌雄大鼠的无观察到有害作用水平（NOAEL）均为150mg/kg/天。
