目的:对含纳豆激酶、银杏叶提取物、紫苏籽油复配物软胶囊进行毒理学安全性评价研究。方法:取软胶囊内容物样品,对SPF级健康昆明种小鼠进行急性经口毒性试验,遗传毒性试验(包括Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验),并选择SPF级健康SD种大鼠进行30 d喂养试验。结果:急性经口试验小鼠在最大给药量30000 mg/kg BW的剂量下生长发育情况良好,培养14 d未见动物死亡,解剖动物各脏器没有发现明显异常改变,根据分级标准,该样品属无毒级;Ames试验、小鼠骨髓细胞微核试验、小鼠精子畸形试验均为阴性;大鼠灌胃试验的30 d内,样品各剂量组的各项指标与对照组比较,均没有显著性差异(P>0.05),解剖观察和组织学检查结果表明,纳豆银杏紫苏胶囊样品对大鼠各器官和组织均无损害作用。结论:在本实验条件下,纳豆银杏紫苏胶囊安全性好,对动物健康无损害作用和毒副作用。
The toxicological safety of soft capsule containing natto kinase,ginkgo biloba extract and Perilla seed oil was evaluated.The contents of soft capsule were sampled,and the SPF grade healthy Kunming mice were selected for acute oral toxicity test,genetic toxicity test(Ames test,mouse bone marrow cell micronucleus test,mouse sperm abnormality test),and the SPF grade healthy SD rats were selected for 30 days feeding test.It is found that the mice in the acute transoral test grew well under the maximum dose of 30,000mg/kg BW,and no death was found after 14 days of culture,and no obvious abnormal changes were found in the organs after dissection.According to the grading standards,the sample was non-toxic.Ames test,mouse bone marrow cell micronucleus test and mouse sperm abnormality test were all negative.During 30 days of intragastric administration,there was no significant difference between the indexes of each dose group and the control group(P>0.05).The results of anatomical observation and histological examination show that the samples had no damage to the organs and tissues of the rats.It is concluded that under the conditions of this experiment,natto ginkgo Perilla capsule is safe and has no harmful effects on animal health.
Journal of Hubei University of Technology
ginkgo biloba extract
perilla seed oil