家蚕基因工程表达系统的安全性研究

THE STUDY OF SECURITY OF THE SILKWORM GENE EXPRESSION SYSTEM

目的 对家蚕基因工程表达系统（Ｂｍ ＮＰＶ）的安全性进行研究，以确保该表达系统及其产品对人的安全。方法 用细菌培养以及ＰＣＲ扩增技术对家蚕的多种成份进行了人类常见病原体的检测；并将蚕的多种成份采用腹腔注射或经口灌胃给受试动物，进行毒理学的初步试验。结果 家蚕体内的多种成分未分离到常见的病原菌，病毒等其它病原体除ＥＢ、ＨＰＶ 病毒ＰＣＲ检测样本有一区带出现外，其余都为阴性；蚕的多种成份对所试动物为无毒级，小鼠微核试验阴性，多角体病毒ＤＮＡ和蛋白生殖毒性试验未见畸形。结论 家蚕体内无人类常见病原体寄生，在ＥＢ、ＨＰＶ 病毒ＰＣＲ结果中出现的部分区带需进一步的证实；可初步认为家蚕基因工程表达系统本身无毒性。

Aim\ Study the security of the silkworm gene expression system in order to appy it to medicine and pharmacy.Method\ Several elements extracted from silkworm were incubated for detecting bacteria.The positive fragment of the samples were also not observed by PCR;this elements were toxicologically evaluated by i.p or oral administration to the mice.Result\ Pathogenic bacteria were not detected in the specimens,positive fragments were not observed except there was a fragment in EB and HPV,all samples were low toxic level,Micronucleus test is very low,reproductive toxicology test has no abnormality.Conclusion\ Pathogens fail to infect the silkworm,the fragment of EB and HPV in some samples must be futher detected.Preliminary tests indicated that silkworm gene expression system itself is safe.