Ⅰ号软胶囊遗传毒性实验研究

Study on the Genetic Toxicity Experiment of TypeⅠCapsule

目的采用生物检测技术评价Ⅰ号软胶囊是否有急性经口毒性及遗传毒性,为其应用安全性提供依据。方法依据《保健食品安全性毒理学评价程序和检验方法规范》2003年版,进行了小鼠最大耐受量(MTD)的测定、小鼠骨髓嗜多染红细胞微核试验及小鼠精子畸形试验。结果小鼠最大耐受量(MTD)大于74.08g·kg^(-1),相当于临床成人用量的1111.2倍;灌胃给予该受试物2.5g·kg^(-1)-10.g·kg^(-1)对小鼠体细胞及雄性生殖细胞无诱变性。结论在本受试剂量范围内Ⅰ号软胶囊无毒性,也未发现有遗传毒性。

OBJECTIVE To estimate the genetic toxicity and acute oral toxicity of typeⅠCapsule and provide the bases for its application safety by the biologic measure technology. METHODS Experiments of micronucleus test of chromat-philic erythrocytes in bone marrow and aberrance of mice sperm were carried out,and the maxium tolerance dose of typeⅠCapsule to mice were measured,according to the ＂Technical Standards for Testing Assessment of Health Food ＂2003. RESULTS The maxium tolerance dose of type Ⅰ Capsule to mice was higher than74. 08g·kg^（-1）,which has equal to clinical adults＇ 1111. 2 times. The typeⅠCapsule has no mutagenicity to somatocell and male germ cells of mice at the range from 2. 5g·kg^（-1） to 10g·kg^（-1） by gastric injection. CONCLUSION TypeⅠCapsule has no toxicity in the dose range from 2. 5g·kg^（-1） to 10. 0g·kg^（-1）,as well as the genetic toxicity has not been found.