口服转鲑鱼降钙素基因酵母的安全性评价

以小鼠为实验对象对表达鲑鱼降钙素的转基因酵母进行了毒理学实验,包括急性毒性实验、遗传毒性实验(小鼠骨髓微核实验、小鼠精子畸形实验)、传统致畸实验和大鼠30 d喂养实验.结果表明,急性毒性实验显示LD50>10.0 g/kg,属于实际无毒物质;遗传毒性实验结果均为阴性,显示无致突变性;致畸实验结果表明转鲑鱼降钙素基因酵母对小鼠不会产生母体毒性,对小鼠胚胎发育无影响且无致畸作用;30 d喂养实验中各项检测指标均无显著差异(p>0.05),组织病理切片检查未发现病理性变化.本文的结论是口服转鲑鱼降钙素基因酵母未对实验动物造成不良影响,是安全无毒的.

Safety Evaluation of Recombinant Sacchromyces cerevisiae Expressing Salmon Calcitonin by Orally Administration

To evaluate the toxicological safety of recombinant Sacchromyces cerevisiae expressing salmon calcitonin,tests included acute toxicity test,micronucleus test,sperm shape abnormality test,traditional teratogenicity test and 30 days feeding test were performed.Results showed oral LD_(50) was higher than 10.0 g/kg both in male and female mice.Micronucleus test and Sperm shape abnormality test were negative.There was no maternal toxicity or embryotoxicity in teratogeniccity test.No significant toxicity was detected in 30 days feeding test.Conclusion could be drawn that recombinant Saccharomyces cerevisiae expressing salmon calcitonin has no negative influences on the animal,which proves that it is safe and nontoxic.