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目的:碘[131I]肝癌细胞膜单抗Hepama1注射液及其肝癌细胞膜单抗Hepama1溶液注射小鼠后的急性毒性试验。方法:小鼠一次尾静脉注入肝癌细胞膜单抗Hepama1溶液0.4mg单抗/20g或碘[131I]肝癌细胞膜单抗Hepama1注射液74MBq/20g,观察小鼠的急性毒性反应。结果:试验组鼠全部存活,一般状态正常,体重增长,未见明显急性毒副反应。结论:该药品及其载体在指定的给药方式条件下,在小鼠体内没有引起明显的急性毒副反应
OBJECTIVE: To evaluate the acute toxicity of 131I hepatoma cell membrane monoclonal antibody Hepama1 injection and hepatocellular carcinoma monoclonal antibody Hepama1 solution injection. METHODS: The mice were treated with a hepatoma cell membrane monoclonal antibody Hepama 1 solution of 0.4 mg monoclonal antibody/20g or iodine [131I] hepatoma cell membrane monoclonal antibody Hepama 1 injection 74 MBq/20 g. The mice were observed for acute toxicity. RESULTS: All rats in the experimental group survived, were in normal condition, and gained weight. No obvious acute toxicity was observed. Conclusion: The drug and its carrier did not cause obvious acute side effects in mice under the specified conditions.