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[目的]研究氯霉素大鼠4周(28 d)经口染毒毒性,为其安全性评价提供毒理学相关参数。[方法]80只健康Wistar大鼠雌雄各半,随机分为1个对照组(5 g/L羧甲基纤维素钠溶液)和3个染毒组(高、中、低剂量组,氯霉素染毒剂量分别为60.0、30.0、7.5 mg/kg),每组20只,经口染毒,连续28 d。观察氯霉素对大鼠体重、血液指标及脏器系数的影响,并进行骨髓涂片及组织病理学检查。[结果]与对照组相比,高剂量组雄性大鼠第2周起体重增长受到抑制(P<0.05),雌、雄大鼠平均红细胞容积、总蛋白、白蛋白降低(P<0.05),雄性大鼠脑脏器系数与雌、雄大鼠肾脏脏器系数升高(P<0.05);中剂量组雌、雄大鼠平均红细胞容积、总蛋白、白蛋白降低(P<0.05),雄性大鼠肾脏脏器系数升高(P<0.05);低剂量组大鼠各指标均未见明显改变。本试验条件下,大鼠氯霉素连续28 d经口染毒未观察到损害作用剂量为7.5 mg/kg,基准剂量为1.284 mg/kg,基准剂量下限为0.804 mg/kg,人类每日容许摄入量为8.04μg/kg。[结论]氯霉素对雄性大鼠的毒性大于雌性大鼠。本研究为氯霉素每日摄入量安全限值的制定及风险评估提供了重要的数据参考。
[Objective] To study the oral toxicity of chloramphenicol in rats for 4 weeks (28 days), and provide toxicological parameters for its safety evaluation. [Method] Eighty healthy Wistar rats were divided into two groups randomly, one control group (5 g / L sodium carboxymethyl cellulose solution) and three exposure groups (high, medium and low dose groups, Su-dose doses were 60.0,30.0,7.5 mg / kg), each group of 20, oral exposure, continuous 28 d. Observe chloramphenicol on body weight, blood parameters and organ coefficient, and bone marrow smear and histopathological examination. [Results] Compared with the control group, the weight gain of the male rats in the high dose group was inhibited at the second week (P <0.05), and the average volume of red blood cells, total protein and albumin in the male and female rats decreased (P <0.05) The index of rat organ in the brain and the index of organ in the male and the female rats increased (P <0.05). The average volume of red blood cells, total protein and albumin in the male and female rats in the middle dose group decreased (P <0.05) The organ coefficient increased (P <0.05). There was no significant change in the indexes of low dose group. Under the test conditions, the rats were chloramphenicol orally for 28 consecutive days did not observe the damage dose of 7.5 mg / kg, the base dose of 1.284 mg / kg, the baseline dose limit of 0.804 mg / kg, human daily allowable The intake was 8.04 μg / kg. [Conclusion] Chloramphenicol is more toxic to male rats than female rats. This study provides an important data reference for the establishment of the safety limit of daily intake of chloramphenicol and risk assessment.