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目的为蛤蜊胶囊安全性评价提供毒理学依据。方法采用急性毒性试验,小鼠骨髓细胞微核试验、小鼠精子畸形试验、Ames试验和30天喂养试验。结果雌雄小鼠经口最大耐受剂量(MTD)均>15 000 mg/kg.BW。Ames、小鼠骨髓微核和精子畸形试验未发现致突变作用。30天喂养体重、增重、摄食量、食物利用率、肝、肾、脾和睾体比、血液、血生化和病理组织学检查与对照组试验动物比较差异均无统计学意义。结论蛤蜊胶囊毒性属无毒级,未见潜在致突变作用,大鼠30天喂养试验未观察到有害作用,最大剂量(NOAEL)为4 800 mg/kg.BW。
Objective To provide a toxicological basis for the safety evaluation of clam capsules. Methods Acute toxicity test, mouse bone marrow micronucleus test, mouse sperm abnormality test, Ames test and 30-day feeding test were used. Results The maximum oral tolerance dose (MTD) in both sexes was> 15 000 mg / kg.BW. Ames, mouse bone marrow micronucleus and sperm deformity test found no mutagenic effect. The body weight, weight gain, food intake, food utilization rate, liver, kidney, spleen and testis ratio, blood, blood biochemical and histopathological examination on the 30th day were not significantly different from those of the control group. Conclusion The clam capsule is non-toxic and has no potential mutagenic effects. No adverse effects were observed in the 30-day feeding test in rats, with a maximum NOAEL of 4 800 mg / kg BW.