Sasaki M, Kawaguchi K, Yamada H, Kobayashi Y, Yamamoto H
Jpn J Antibiot. 1986 Dec;39(12):3291-310.
Teratological study of isepamicin (HAPA-B), a new aminoglycoside antibiotic, was performed in Jcl: Wistar rat. The drug was given intramuscularly to dams at doses of 25, 100 and 200 mg/kg from day 7 to 17 after mating. The influence on dams, their fetuses and offspring was studied. A decrease in food intake and a development of pale color of the kidney of dams at a dose level of 200 mg/kg were observed in the prenatal study. The HAPA-B did not show any influence on prenatal development of fetuses. In the postnatal study, no effect of HAPA-B on parturition and lactation of dams was seen except that a discoloration of the kidney was observed at autopsy. However, some differences were observed between the control and treatment groups in postnatal development, behavior and reproduction performance of offspring. Dose-response effects of HAPA-B on offspring were not observed in the postnatal study. No effect dose levels of HAPA-B established in this study on rat fetuses and offspring were 200 mg/kg and 100 mg/kg on pregnant rat, respectively.
对新型氨基糖苷类抗生素异帕米星（HAPA - B）进行了致畸学研究，实验对象为日本实验动物中央研究所的Wistar大鼠。在交配后第7天至第17天，以25、100和200mg/kg的剂量给孕鼠肌肉注射该药物。研究了其对孕鼠、胎儿及后代的影响。产前研究中，在200mg/kg剂量水平下观察到孕鼠食物摄入量减少以及肾脏颜色变浅。HAPA - B对胎儿的产前发育未显示任何影响。产后研究中，除尸检时观察到肾脏变色外，未发现HAPA - B对孕鼠分娩和哺乳有任何影响。然而，在后代的产后发育、行为和繁殖性能方面，对照组和治疗组之间观察到一些差异。产后研究中未观察到HAPA - B对后代的剂量反应效应。本研究确定的HAPA - B对大鼠胎儿和后代的无效应剂量水平，对孕鼠分别为200mg/kg和100mg/kg。
