Yamakita O, Koida M, Shinomiya M, Katayama S, Ikebuchi K, Ohuchida A, Kouchi Y, Yoshida R
Drug Safety Laboratory, Taiho Pharmaceutical Co., Ltd., Tokushima-shi.
J Toxicol Sci. 1988 Jun;13 Suppl 1:215-29. doi: 10.2131/jts.13.supplementi_215.
Peri- and postnatal study of cefodizime sodium (THR-221), a new developed cephem-type antibiotics, was carried out with ICR mice. THR-221 at dose levels of 0, 300, 1000 and 3000 mg/kg/day were administered intravenously to pregnant and delivered dams from day 15 of gestation through day 21 of lactation. No changes in body weights of dams in all treated groups but slight decrease in food consumptions of 3000 mg/kg/day group were observed. Treated sites, tails of a few dams in this group, were affected with inflammatory lesions because of repeated dosing. Neonates from dams treated with 3000 mg/kg/day were slightly decreased in body weight at birth. At term sacrifice of F 1 of 10 weeks age, absolute and relative spleen weights were decreased in male 3000 mg/kg/day group and in female 1000 and 3000 mg/kg/day group. No effects on other physical, behavioral or reproductive ability examinations of F 1 offspring were showed. It is suggested that no effect dose level of THR-221 is 1000 mg/kg/day and that of F 1 offspring is 300 mg/kg/day.
用ICR小鼠对新开发的头孢菌素类抗生素头孢地嗪钠(THR-221)进行了围产期和产后研究。从妊娠第15天至哺乳期第21天,对怀孕和分娩后的母鼠静脉注射剂量水平为0、300、1000和3000mg/kg/天的THR-221。所有治疗组的母鼠体重均无变化,但3000mg/kg/天组的食物摄入量略有下降。由于反复给药,该组几只母鼠的治疗部位(尾巴)出现炎症性病变。3000mg/kg/天组母鼠所产新生仔鼠出生时体重略有下降。在对10周龄的F1代进行足月处死后,3000mg/kg/天雄性组以及1000和3000mg/kg/天雌性组的脾脏绝对重量和相对重量均下降。未显示对F1代后代的其他身体、行为或生殖能力检查有影响。提示THR-221的无影响剂量水平为1000mg/kg/天,F1代后代的无影响剂量水平为300mg/kg/天。