莲子心总生物碱的毒性试验研究

摘要 目的： 探讨莲子心总生物碱的毒副作用，以对莲子心总生物碱作出安全性评价。方法 ：小鼠急性毒性试验中一次性给予最大灌胃量5000mg/kg莲子心总生物碱，观察小鼠中毒症状。长期口服毒性实验，Sprague-Dawley(SD)大鼠随机分为四组，分别按照400mg/kg?d、200 mg/kg?d、100 mg/kg?d的剂量给予SD大鼠灌胃实验室自制莲子心总生物碱，对照组给予等量体积0.3%羧甲基纤维素钠，连续服用30天。结果 ：在急性毒性试验中给予5000mg/kg莲子心总生物碱对小鼠不产生毒性作用。在长期毒性试验中，除不同剂量给药组SD大鼠血清尿素氮与对照组具有显著性差异(P<0.05)，高、中剂量组SD大鼠血糖含量与对照组有明显差异(P<0.05)外余下指标与对照组相比均无明显差异。高、中、低剂量组大鼠肝组织病理切片与对照组相比均明显异常，表现为肝小叶结构正常。结论 ： 莲子心总生物碱对小鼠最大耐受剂量为5000mg/kg，同时灌胃给药400mg/kg/天莲子心总生物碱对大鼠无毒副作用。

The Toxicological Study on Total Alkaloids Extracted from Lotus Plumula

ABSTRACT Objective:To confirm the safe use of the total alkaloids extracted from lotus plumula in rats. Methods: In acute toxicity study, total alkaloids were administrated by oral gavage at a dose of 5000mg/kg. In long-term toxicity study, the total alkaloids of 400,200and 100 mg/kg/day were given orally to groups of rats for 30 consecutive days. Results:The total alkaloids at a dose of 2000mg/kg produced no signs of toxicity or mortality in any of the tested animals.In the long-term toxicity tests, there was no significant difference in serum biochemical parameters except that serum urea nitrogen and blood glucose levels at the highest group were different form that of the control group((P >0.05).No abnormality of internal organs was observed in histopathological examinations. Conclusions: The results suggest that the maximum tolerated dose of total alkaloids extracted from lotus plumula in mice was 5000mg/kg and the no-observed-adverse-effect level of the total alkaloids in rats is considered to be 400mg/kg/day.