水飞蓟提取物的急性毒性、遗传毒性和亚慢性毒性研究

Acute toxicity,genotoxicity and subchronic toxicity of Silymarine marianum extract

目的研究水飞蓟提取物的急性毒性、遗传毒性和亚慢性毒性。方法根据GB 15193.3-2003、GB 15193.4-2003、GB 15193.5-2003、GB 15193.7-2003、GB 15193.13-2003,采用小鼠急性经口毒性试验、三项遗传毒性试验(Ames试验、骨髓嗜多染红细胞微核试验、小鼠精子畸形试验)、90 d喂养实验对水飞蓟提取物的安全性毒理学进行研究。结果水飞蓟提取物对雌、雄昆明种小鼠的最大耐受剂量(MTD)均大于20.0 g/kg·bw,属无毒级;Ames试验、骨髓嗜多染红细胞微核试验、小鼠精子畸形试验结果均为阴性,90 d喂养试验各剂量组大鼠体重增加、食物摄入量、食物利用率、脏器/体重比值与对照组比较均无异常,血液学指标和生化指标值在正常范围内,大鼠主要脏器组织未见有意义的病理学改变;未观察到有害作用剂量大于2.5 g/kg·bw。结论在本实验条件下,水飞蓟提取物未见明显毒副作用。

Objective To study the acute toxicity, genotoxicity and subchronic toxicity of Silymarine marianum extract.Methods According to GB 15193.3 2003, GB 15193.4 2003,GB 15193.5 - 2003,GB 15193.7- 2003 and GB 15193.13- 2003, acute oral toxicity test, Ames test, bone marrow cell micronucleus test, mice sperm abnormality test and 90 - day feed-ing study were used to assess the safety of Silymarine marianum extract. Results The maximum tolerated doses（MTDs）ofSilymarine marianum extract in female and male Kunming mice were both greater than 20.0 g/kg-1 bw, which belonged to non -toxic class. Ames test, bone marrow cell micronucleus test and sperm shape abnormality test were negative. No significant differ-ences were found in body weight gain, food intake, food utilization rates and the ratio of organ weight to body weight betweenthe test groups and the control group in 90 d feeding study. Haemotologieal parameters and serum biochemical indices all fell intothe ranges of normal values. No meaningful histological changes were observed in the rats＇ main tissues. The no- observed - ad-verse - effect - level （NOAEL） in rats was greater than 2.5 g/kg-1 bw. Conclusions No significant toxic effects are found forSilymarine marianum extract in this study.