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作 者:赵兰华[1] 刘玮[1] 唐双阳[1] 李冉辉[1] 曾焱华[1]
机构地区:[1]南华大学病原生物学研究所特殊病原体防控湖南省重点实验室,湖南衡阳421001
出 处:《中南医学科学杂志》2016年第5期575-578,共4页Medical Science Journal of Central South China
基 金:衡阳市科学技术发展计划项目(NO:2016KJ67);国家自然科学基金资助(NO:2013GZK09);特殊病原体防控湖南省重点实验室资助项目(湘科计字[2014]5号);湖南省分子靶标新药研究协同创新中心资助项目(湘教通[2015]351号)
摘 要:目的筛选有佐剂效果的纳米乳新配方,并从稳定性、粒径大小、载水范围、佐剂效果与安全性等方面评价其作为疫苗佐剂的可行性。方法依据伪三元相图筛选出能被水大量稀释的配方,测定基本性质如p H,黏度,粒径,长期保存或离心条件下是否保持稳定等。将其做为佐剂与流感疫苗混合进行动物实验。25只ICR小鼠随机分为生理盐水组、单独疫苗组、铝佐剂对照组、弗氏佐剂组和纳米乳佐剂组,每组5只,经大腿腓肠肌注射流感H3N2裂解疫苗。第三周加强免疫一次,初次免疫后一周内观察各组小鼠的体重变化,每周收集血清以检测血凝抑制抗体的效价,用SPSS18.5软件分析比较各组小鼠产生的抗体水平。最大给药量实验评价其安全性。结果该纳米乳理化性质稳定,p H值为7.5,黏度与水接近,平均粒径为56.3 nm,离心及长期保存不破乳。纳米乳佐剂组小鼠能产生更高水平的血凝抑制抗体,在0.25 mg/10 g给药量下无小鼠死亡。结论该纳米乳配方作为流感疫苗佐剂具有良好的稳定性、安全性及佐剂效果。Objective To screen a new Nano-emulsion fomula with good efficiency,high stability,good safety,suitable particle size and large water capacity to evaluate its feasibility when used as vaccine adjuvant. Methods Nano-emulsions that can be diluted by plenty of water was selected based on pseudo-ternary phase diagram,the basical properties such as PH,viscosity,partical size,stability when centrifuged or long-stem storedweretested. And the emulsion was mixed with influenza vaccine for animal experiments.ICR mice were randomly divided intonormal saline group,single vaccine group,aluminium adjuvant control group,Freund's adjuvant group and nano emulsion adjuvant group. All mice were immuned by gastrocnemius muscle and weighed within a week.The second immunization was performed at the third week.Sera were collected every week after the second immunization. Finally,the titer of hemagglutination inhibition( HI) antibody was detected and analyzed by SPSS 18.5 software.The maximum dosage experiment was performed to evaluate its safety. Results The emulsion showed stable physical and chemical properties,the PH value was 7.5,viscosity close to water,and the average particle size was 56.3nm,no demulsification was observed when centrifugedor long-term stored.The mice of Nano emulsion adjuvant group had a significantly higher antibody level than that of other groups in animal test. Finally,the dosage of 0.25 mg/10 g caused no mice death. Conclusions The nano-emulsion formula was a good adjuvant with stability,safety and good efficacy.
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