中国药物警戒 ›› 2013, Vol. 10 ›› Issue (12): 709-711.

• 基础及临床研究 • 上一篇    下一篇

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

吴鸠虎飞,曹春然*,孙圆媛,胡宇驰   

  1. 北京市药品检验所药物安全评价中心,北京100035
  • 收稿日期:2013-07-22 修回日期:2016-03-09 出版日期:2013-12-08 发布日期:2016-03-09
  • 通讯作者: 曹春然,女,硕士,副主任药师,药物安全评价。Ｅ-mail:cchunran@vip.sina.com
  • 作者简介:吴鸠虎飞,男,博士,主管药师,药物安全评价。

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

WU Xiao-fei, CAO Chun-ran* ,SUN Yuan-yuan ,HU Yu-chi   

  1. Drug Safety Evaluation Center, Beijing Institute for Drug Control, Beijing 100035, China
  • Received:2013-07-22 Revised:2016-03-09 Online:2013-12-08 Published:2016-03-09

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摘要： 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。

关键词: 治疗用皮卡乙型肝炎疫苗（CHO细胞）, 急性毒性反应, 小鼠

Abstract: Objective To compare the acute toxicity reaction of PIKA hepatitisB therapeutic vaccine(CHO cell) and its component on mice,which is PIKA adjuvant and recombinant hepatitisB vaccine(CHO cell). Methods ICR mice were randomized into solvent control 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 and2 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 14d 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.

Key words: PIKA hepatitis B therapeutic vaccine(CHO cell), acute toxicity reaction, mice

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