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目的:研究抗动脉粥样硬化核酸疫苗的安全性。方法:观察该质粒在小鼠组织中的分布和急性毒性, 并在正常给药的情况下对新西兰大白兔进行6 个月毒性试验。采用肌肉注射20μg/ 只和100μg/ 只, 用PCR 法检测外源基因在小鼠组织的分布和存留时间;同样采用肌肉注射, 对最高剂量达到50mg/kg 体重的小鼠进行急性毒性试验。结果:实验证明该核酸疫苗在注射部位可存留时间为8 周, 其他组织如心、肝、脾、肺、肾、脑和生殖器官也有低水平分布, 急毒试验显示, 在剂量达到有效剂量的60 倍的情况下, 无可观察到的毒性反应发生, 小鼠血液学和生化指标亦无异常;新西兰大白兔毒性观察, 体内生化指标以及解剖学研究结果表明, 该药无可观察到的毒性反应发生。结论:该核酸疫苗无可观察到的明显毒性反应, 安全性良好。

英文摘要:

Objective :To evaluate the safety of the DNA vaccine against the atherosclerosis .Methods :80 ICR mice were divided into low dosage group(n=30 , DNA vaccine 20μg each), high dosage group(n =30 , DNA vaccine 100μg each), and control group(n =20, normal saline);15 New Zealand white rabbits were randomly divided into three groups:normal saline control group, DNA plasmid group and DNA vaccine group, equally .The vaccine' s tissue distribution and acute toxicity in mice were investigated, and its toxicity on New Zealand white rabbit was also evaluated in our studies.Plasmid DNA was detected by PCR in doses of 20μg and 100μg IM .Its dose was up to 1000μg in the acute toxicity .The toxicity on the New Zealand white rabbits was observed in the normal dose .Results :The muscle tissue distribution was kept for eight weeks , which was longer than other tissues, such as liver , spleen, lung , kidney and brain .The acute toxicity showed that when the maximum dose was 60 times as much as the normal dose , there was no toxicity influence on the hematology and biochemical indicators of the mice and the rabbits.Conclusion :In our studies, it is suggested that the DNA vaccine is safe for the atherosclerosis treatment .

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