治疗用皮卡乙型肝炎疫苗(CHO细胞)及其组分的小鼠急性毒性实验研究

Experimental Study of Acute Toxicity of PIKA Hepatitis B Therapeutic Vaccine(CHO Cell) and Its Component on Mice

目的比较治疗用皮卡乙型肝炎疫苗(CHO细胞)及疫苗组分(重组乙型肝炎疫苗(CHO细胞)、皮卡佐剂)对小鼠的急性毒性反应。方法 ICR小鼠按体重随机分为溶媒对照组,皮卡佐剂高剂量组(原液)和低剂量组(2倍稀释液),重组乙型肝炎疫苗(CHO细胞)组(原液),治疗用皮卡乙型肝炎疫苗(CHO细胞)高剂量组(原液)和低剂量组(2倍稀释液),每组小鼠后肢im 0.2mL受试物,给药后连续14天观察其状态及毒性反应。结果各组小鼠全部存活,摄食和体重指标正常,注射部位肌肉、外观体征、行为活动、呼吸、排泄、各组织脏器肉眼观察及组织病理学检查均未见异常。结论在本实验条件下,治疗用皮卡乙型肝炎疫苗(CHO细胞)及疫苗组份对小鼠无明显毒性反应。

Objective To compare the its component on mice,which is PIKA were randomized into solvent control acute toxicity reaction of PIKA hepatitis B therapeutic vaccine（CHO cell） and adjuvant and recombinant hepatitis B vaccine（CHO cell）. Methods ICR mice group, high dose and low dose（PIKA adjuvant stoste and 2 times diluent） of PIKA adjuvant groups, recombinant hepatitis B vaccine（CHO cell） and high dose and low dose（vaccine stoste and 2 times diluent） of PIKA hepatitis B therapeutic vaccine（CHO cell）. Mice were administrated intramuscularly once with tested drugs（0.2 mL） and continuously observed for 14 d for acute toxicity symptoms. Results All mice of every group survived and there were no toxicological changes in body weight, feed consumption, injection agents, appearance, behavioral activity, respiratory system, dejecta, organ macroscopic and pathological examination related to the tested drugs. Conclusion There is no obvious acute toxicity reaction on mice treated with PIKA hepatitis B therapeutic vaccine（CHO cell） and its component.