国际生物制品学杂志
國際生物製品學雜誌
국제생물제품학잡지
INTERNATIONAL JOURNAL OF BIOLOGICALS
2014年
5期
209-211
,共3页
吴虓飞%金鑫%胡宇驰%吕晶
吳虓飛%金鑫%鬍宇馳%呂晶
오효비%금흠%호우치%려정
流感疫苗%肌肉刺激%急性毒性试验%过敏反应
流感疫苗%肌肉刺激%急性毒性試驗%過敏反應
류감역묘%기육자격%급성독성시험%과민반응
Influenza vaccines%Intramuscular stimulation%Acute toxicity tests%Anaphylaxis
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.
目的 對四價流感病毒裂解疫苗進行肌肉刺激性、急性毒性和過敏性評價,以攷察其安全性.方法 對傢兔後肢股四頭肌肌肉註射0.5 ml四價流感病毒裂解疫苗,每天接種1次,連續接種2d,末次接種後48 h和16d對註射部位進行肉眼和病理組織學檢查.對小鼠後肢肌肉註射0.2 ml疫苗後,連續4h和14d觀察各種不良反應.豚鼠後肢隔天肌肉註射0.5 ml疫苗,共接種緻敏3次,分彆于末次接種後14和21 d靜脈註射1.0 ml疫苗進行激髮,觀察豚鼠30 min內是否齣現過敏反應.結果 傢兔在末次接種後48 h和16 d,未觀察到明顯的跼部刺激作用.小鼠接種後全部存活,攝食量和體重指標正常,註射部位肌肉、外觀體徵、行為活動、呼吸、排洩、各組織髒器肉眼觀察均未見異常.豚鼠靜脈註射疫苗後,活動正常,未齣現1-20級過敏反應癥狀,全身主動過敏反應呈陰性.結論 四價流感病毒裂解疫苗無肌肉刺激性、急性毒性,不引髮全身主動過敏性反應.
목적 대사개류감병독렬해역묘진행기육자격성、급성독성화과민성평개,이고찰기안전성.방법 대가토후지고사두기기육주사0.5 ml사개류감병독렬해역묘,매천접충1차,련속접충2d,말차접충후48 h화16d대주사부위진행육안화병리조직학검사.대소서후지기육주사0.2 ml역묘후,련속4h화14d관찰각충불량반응.돈서후지격천기육주사0.5 ml역묘,공접충치민3차,분별우말차접충후14화21 d정맥주사1.0 ml역묘진행격발,관찰돈서30 min내시부출현과민반응.결과 가토재말차접충후48 h화16 d,미관찰도명현적국부자격작용.소서접충후전부존활,섭식량화체중지표정상,주사부위기육、외관체정、행위활동、호흡、배설、각조직장기육안관찰균미견이상.돈서정맥주사역묘후,활동정상,미출현1-20급과민반응증상,전신주동과민반응정음성.결론 사개류감병독렬해역묘무기육자격성、급성독성,불인발전신주동과민성반응.
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.
