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目的研究重组巴曲酶(rBAT)连续静脉注射30d对大鼠的长期毒性。方法健康SD大鼠按体重随机分为低、中、高剂量组(3.0、10.0、30.0KU·kg-1)和溶媒对照组(n=20)。连续30d尾静脉注射给药。末次给药后处死一半动物做病理解剖,另一半停药后继续观察15d。观察症状和检测指标包括:一般症状;血液学指标;血液生化指标;凝血指标;非特异性免疫学检查;抗体检测;病理检查等。结果rBAT可能对大鼠的CT有一定的影响,且不同剂量对CT的作用不同;rBAT能显著降低大鼠血浆Fig含量,且呈剂量依赖性。30d雄性大鼠血清ALT呈剂量依赖性的升高。以上作用均是可逆的。结论rBAT对大鼠凝血系统及肝功能有一定的可逆的毒性作用。大鼠静脉注射rBAT的安全剂量为3KU·kg-1。
Objective To study the long-term toxicity of recombinant batroxobin (rBAT) to rats for 30 days. Methods Healthy SD rats were randomly divided into low, medium and high dose groups (3.0, 10.0, 30.0 KU · kg -1) and vehicle control group (n = 20) according to body weight. 30d tail vein injection administration. After the last administration, half of the animals were sacrificed for pathological anatomy, while the other half were stopped for observation 15 days later. Observed symptoms and test indicators include: general symptoms; hematological indicators; blood biochemical indicators; coagulation indicators; non-specific immunological tests; antibody test; pathological examination. Results rBAT may have some effect on CT in rats, and the effect of different dose on CT is different. RBAT can significantly reduce the content of Fig in plasma of rats, in a dose-dependent manner. Serum ALT in 30d male rats increased in a dose-dependent manner. The above effects are reversible. Conclusion rBAT has a certain reversible toxic effect on the coagulation system and liver function in rats. Rat intravenous rBAT safe dose of 3KU · kg-1.