重组溶葡萄球菌酶对大鼠的毒性试验

观察重组溶葡萄球菌酶经口给药对大鼠的急性毒性和长期毒性。急性毒性试验中,大鼠以每千克体重5 000 mg的剂量口服重组溶葡萄球菌,观察中毒症状并测定LD50。长期毒性试验中,大鼠以每天每千克体重口服72,360,1 800 mg重组溶葡萄球菌酶,连续给药180 d,观察给药后45 d、90 d、135 d和180 d时大鼠的生长发育、血液学、血液生化学、组织病理变化。结果表明,重组溶葡萄球菌酶口服对大鼠的LD50大于5 000 mg/kg,长期毒性试验未见明显毒性反应。说明重组溶葡萄球菌酶在规定剂量下使用是安全可靠的。

Toxicity test of recombinant lysostaphin to rats

The experiment was conducted to observe the acute toxicity of recombinant lysostaphin(rlysostaphin) and its long-period toxicity to rats.In the acute toxicity experiment,the rats were orally administrated rlysostaphin at a dosage of 5 000 mg/kg,and then the symptoms were observed and 50 percent lethal dose(LD50) was calculated.In the long-period toxicity experiment,the rats were orally administrated rlysostaphin at different dosages of 72,360,180 mg/kg,and the administrations were lasted for 180 d.Body weight,hematological and hematobiochemical parameters,and histopathological changes were measured in rats at 45 d,90 d,135 d and 180 d after oral administration.The results showed that the LD50 of rlysostaphin was over 5 000 mg/kg in rat.No significant toxic effects were found in the rats with a long-term oral administration.The results indicated that rlysostaphin is safe to use in accordance with the prescribed dose.