一类新药尖吻蝮蛇凝血酶对SD大鼠围产期生殖毒性试验

Perinatal reproductive toxicity of Halase in perinatal Sprague-Dawley rats

目的观察一类新药尖吻蝮蛇凝血酶对大鼠生殖功能的毒性或干扰作用,为临床用药提供依据。方法对一类新药尖吻蝮蛇凝血酶进行大鼠围产期生殖毒性试验:雌鼠从妊娠第15日至F1代大鼠离乳(出生后第21日)经静脉注射给予不同剂量的尖吻蝮蛇凝血酶(0.1、0.2、0.4 U·kg^(-1))。结果未发现尖吻蝮蛇凝血酶对雌鼠妊娠、哺乳以及胚胎和F1代大鼠生长发育有明显毒性和干扰作用。结论尖吻蝮蛇凝血酶对围产期大鼠无生殖毒性,其大鼠围产期生殖毒性试验的安全剂量为0.4 U·kg^(-1)。

Objective To investigate adverse drug reactions of Halase on reproductive functions in perinatal Sprague-Dawley rats and provide reference of drug safety for clinical medication. Methods For reproduc- tive toxicological evaluation, different doses of Halase （0.1, 0.2, and 0.4 U kg -1） were given to female rats from the 15th day of pregnancy until their F1 rats got weaned （21 days after birth） via intravenous injection. Results No distinct toxicological nor interference effects were observed in the study of pregnant/lactational Sprague-Dawley rats, embryos they gestated and their F1 generations. Conclusion Halase shows no reproduc- tive toxicity in perinatal Sprague-Dawly rats and the safe dose of Halase in repoductive toxicological evaluation during perinatal period is 0.4 U kg - 1.