Study on chronic toxicity of freeze-dried powdered Cassiae Semen in Sprague-Dawley rats
英文关键字：Freeze-dried powder Cassiae Semen; Chronic toxicity; NOAEL; The primary toxicity organ
中文摘要：摘要 目的 研究大鼠连续一年长期食用决明子冻干粉的毒性，为人体食用提供参考依据。方法 决明子冻干粉以0.5、2.2及10.0 g生药/kgBM剂量分别灌胃给予SD大鼠52周，在试验第13、26、39、52周以及分别在给药26、52周后停药恢复4周，分别剖杀20只/组，雌雄各半。结果 在整个试验周期中未发生因给予决明子药物本身引起的大鼠濒死和死亡的毒性反应；各组大鼠体重均增长，且增长速度呈现出一定的剂量-反应关系；给药26周及39周后，2.2和10.0 g生药/kgBM剂量组雄性大鼠的肾脏系数均不同程度地显著性高于对照组（P&lt;0.05或P&lt;0.01）；给药52周后，10.0 g生药/kgBM剂量组发生大鼠肾脏近曲小管上皮细胞内色素沉积，以及引起肾小管萎缩及再生等病理组织学改变，停药恢复4周后，这种现象虽有所缓解但仍然存在。结论 在本试验室条件下，决明子冻干粉的未发生毒性反应的剂量（NOAEL）为2.2 g生药/kgBM，在10.0 g生药/kgBM剂量下的毒性靶器官主要是肾脏。
英文摘要：Abstract Objective We evaluated the toxicity of freeze-dried powdered Cassiae Semen in male and female Sprague-Dawley rats. Methods Rats were intragastrically administered freeze-dried powdered Cassiae Semen at a dose of 0, 0.5, 2.2, or 10.0 g/kg body weight/day for 26 weeks; several variables were assessed after 13 and 26 weeks as well as after a 4-week recovery period. Result No mortality was observed in the treated animals, and body weight increased in the animals in a dose-dependent manner. In males, at 26 and 39 weeks, there were significant increases in relative
kidney weights in the 2.2 and 10.0 g/kg groups compared with that in the 0 g/kg group. Pigment deposition in the epithelial cells of the renal proximal convoluted tubules and atrophy or regeneration of renal tubules were observed in the 10.0 g/kg group after 52 weeks, and these changes were not fully reversed after the 4-week recovery period. Conclusion Under the studied conditions, the No Observed Adverse Effect Level (NOAEL) for freeze-dried powdered Cassiae Semen was 2.2 g/kg in rats, and the primary toxicity organs in the 10.0 g/kg group were the kidneys.