| 四价流感病毒裂解疫苗的安全性研究 |
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| 引用本文： | 吴虓飞,金鑫,胡宇驰,吕晶. 四价流感病毒裂解疫苗的安全性研究[J]. 国际生物制品学杂志, 2014, 37(5): 209-211. DOI: 10.3760/cma.j.issn.1673-4211.2014.05.001 |
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| 作者姓名： | 吴虓飞 金鑫 胡宇驰 吕晶 |
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| 作者单位： | 100035 北京市药品检验所药物安全评价中心 |
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| 摘 要： | 目的 对四价流感病毒裂解疫苗进行肌肉刺激性、急性毒性和过敏性评价,以考察其安全性.方法 对家兔后肢股四头肌肌肉注射0.5 ml四价流感病毒裂解疫苗,每天接种1次,连续接种2d,末次接种后48 h和16d对注射部位进行肉眼和病理组织学检查.对小鼠后肢肌肉注射0.2 ml疫苗后,连续4h和14d观察各种不良反应.豚鼠后肢隔天肌肉注射0.5 ml疫苗,共接种致敏3次,分别于末次接种后14和21 d静脉注射1.0 ml疫苗进行激发,观察豚鼠30 min内是否出现过敏反应.结果 家兔在末次接种后48 h和16 d,未观察到明显的局部刺激作用.小鼠接种后全部存活,摄食量和体重指标正常,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均未见异常.豚鼠静脉注射疫苗后,活动正常,未出现1-20级过敏反应症状,全身主动过敏反应呈阴性.结论 四价流感病毒裂解疫苗无肌肉刺激性、急性毒性,不引发全身主动过敏性反应.
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| 关 键 词： | 流感疫苗 肌肉刺激 急性毒性试验 过敏反应 |
Safety evaluation of a quadrivalent split influenza vaccine |
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| Wu Xiaofei,Jin Xin,Hu Yuchi,Lyu Jing. Safety evaluation of a quadrivalent split influenza vaccine[J]. International Journal of Biologicals, 2014, 37(5): 209-211. DOI: 10.3760/cma.j.issn.1673-4211.2014.05.001 |
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| Authors: | Wu Xiaofei Jin Xin Hu Yuchi Lyu Jing |
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| Affiliation: | Department of Drug Safety Evaluation Center, Beijing Institute for Drug Control, Beijing 100035, China |
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| Abstract: | Objective To evaluate muscular stimulation,acute toxicity and anaphylaxis of a quadrivalent split influenza vaccine for safety investigation.Methods Rabbits were intramuscularly administrated with the vaccine （0.5 ml,once daily for consecutive 2 d）.Macrographic and pathological examinations of injection site were conducted 48 h and 16 d after the last administration.Mice were intramuscularly injected with the vaccine （0.2 ml） and observed continuously for 14 d for acute toxical symptoms.Guinea pigs were intramuscularly administrated with the vaccine （0.5 ml） every other day for 3 times and intravenously injected （1.0 ml） 14 and 21 d after the last sensitization,and then allergic reactions were observed within 30 min.Results The vaccine had no intramuscular irritation or injury effect on the injection site 48 h and 16 d after administration.All mice survived and no toxicological changes were observed in body weight,feed consumption,injection sites,appearance,behavioral activity,respiration,excretion,macroscopic examination of organs and tissues.No allergy symptoms occurred in guinea pigs after intravenous injection.Conclusion There is no intramuscular stimulation,acute toxicity and sensitization of the quadrivalent split influenza vaccine. |
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| Keywords: | Influenza vaccines Intramuscular stimulation Acute toxicity tests Anaphylaxis |
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