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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 acute toxicity of mice treated with the Picaka Hepatitis B vaccine (CHO cells) and the vaccine components (recombinant Hepatitis B vaccine (CHO) and Picaka adjuvant). Methods ICR mice were randomly divided into vehicle control group, high dosage of picocaine (original solution) and low dosage (2-fold dilution), recombinant hepatitis B vaccine (CHO cell) High dose group (original solution) and low dose group (2 times dilution) of Hepatitis B vaccine (CHO cell), each mouse hindlimb im 0.2mL test substance, after administration for 14 days to observe the status and toxicity. Results All the mice survived, their ingestion and body weight index were normal, and the muscles in the injection site, appearance signs, behavioral activities, respiration and excretion were observed. No abnormalities were observed in the macroscopic and histopathological examination of organs. Conclusion Under the conditions of this experiment, there is no obvious toxic reaction in mice treated with the therapeutic hepatitis B vaccine (CHO cells) and vaccine components.