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冻干乙型脑炎减毒活疫苗非动物源性稳定剂的配方及其缓冲液的筛选 被引量:5

Screening of formula and buffer in non-animal-derived stabilizer of freeze-dried live attenuated Japanese encephalitis vaccine
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摘要 目的筛选冻干乙型脑炎减毒活疫苗非动物源性稳定剂的配方及其缓冲液。方法分别以0.01 mol/L PBS和Earles液为缓冲液,右旋糖苷-70、蔗糖、山梨醇、乳糖及组氨酸不同组合构成的冻干稳定剂,制备乙型脑炎减毒活疫苗半成品及冻干疫苗成品,观察在不同温度存放不同时间的稳定性,并检测不同配方冻干稳定剂的崩解温度(Tc)。结果 12种配方冻干稳定剂制成的疫苗半成品可在4℃1周内保持滴度稳定性,在25℃3 d内保持滴度无明显变化,3 d后滴度大幅下降;以0.01 mol/L PBS为缓冲液的稳定剂制备的疫苗的Tc值低于Earles液,以Earles液为缓冲液的D2和F2配方制备的冻干疫苗成品,在4℃及37℃放置1周后,滴度均>5.7 logPFU/ml。结论已筛选出以Earles液为缓冲液,含右旋糖苷-70、蔗糖、山梨醇、乳糖及组氨酸的稳定剂配方,用于制备冻干乙型脑炎减毒活疫苗具有良好的保护效果。 Objective To screen the formula and buffer in non-animal-derived stabilizer of freeze-dried live attenuated Japanese encephalitis(JE) vaccine.Methods Final bulk and final product of freeze-dried live attenuated JE vaccine were prepared by various formula consisting of dextran-70,sucrose,sorbitol,lactose and histidine dissolved in 0.01 mol / L PBS and Earles solution respectively,and evaluated for stabilities after storage at various temperatures for various days.The disintegration temperatures(Tc) of the vaccine containing stabilizers of various formula were measured.Results The stabilities of final bulk of JE vaccine containing stabilizers of twelve formula were maintained after storage at 4℃ for one week.However,the titer of final bulk showed no significant change within 3 d after storage at 25 ℃,and decreased remarkably afterwards.The Tc of vaccine containing stabilizer using 0.01 mol / L PBS as buffer was lower than that using Earles solution.The titers of final product of freeze-dried live attenuated JE vaccines containing the stabilizers of formula D2 and F2 using Earles solution as buffer were more than 5.7 log PFU / ml after storage at 4 and 37 ℃ for one week.Conclusion The stabilizer consisting of dextran-70,sucrose,sorbitol,lactose and histidine using Earles solution as buffer was suitable for freeze-dried live attenuated JE vaccine.
作者 段凯 李黎
出处 《中国生物制品学杂志》 CAS CSCD 2012年第11期1431-1433,共3页 Chinese Journal of Biologicals
关键词 乙型脑炎 减毒活疫苗 冻干 稳定剂 缓冲液 Japanese encephalitis Live attenuated vaccine Freeze-drying Stabilizer Buffer
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  • 1Rottem M. Asthma prevalence and exacerbations in children: is there an association with childhood vaccination [J]. Expert Rev Clin Immunol, 2008, 4 (6): 687-694.
  • 2Fritsche PJ, Helbling A, Ballmer-Weber BK. Vaccine hypersensi- tivity-update and overview[J]. Swiss Med Wkly, 2010, 140 (171): 238-246.
  • 3Pedro EC, Ana CS, Antenio Roldio, et al. Screening of novel ex- cipients for improving the stability of retroviral and adenoviral vectors [J]. Biotechnol Progress, 2006, 2 (22): 568-576.
  • 4Rachakonda PS, Veit M, Korte T, et al. The relevance of salt bridges for the stability of the influenza virus hemagglutinin [J]. FASEB J, 2007, 21 (4): 995-1002.
  • 5Zhou Y, Roos YH. Stability and plasticizing and crystallization effects of vitamins in amorphous sugar systems [J]. J Agric Food Chem, 2012, 60 (4): 1075-1083.
  • 6Imamura K, Kagotani R, Nomura M, et ol. Influence of compres- sion on water sorption, glass transition, and enthalpy relaxation behavior of freeze-dried amorphous sugar matrices [J]. Int J Pharm. 2011, 408 (1-2): 76-83.
  • 7Izutsu K, Kadoya S, Yomota C, et al. Freeze-drying of proteins in glass solids formed by basic amino acids and dicarboxylic acids [J]. Chem Pharm Bull. 2009, 57 (1): 43-48.
  • 8饶永彩,赵丽萍,杜碧琳.pH值对冻干乙脑活疫苗滴度的影响[J].中国生物制品学杂志,1995,8(4):174-174. 被引量:2
  • 9Ohtake S, Martin RA, Yee L, et al. Heat-stable measles vaccine produced by spray drying [J]. 2010, Vaccine, 28 (5): 1275-1284.
  • 10Lang R, Winter G, Vogt L, et al. Rational design of a stable, freeze-dried virus-like particle-based vaccine formulation [J]. Drug Develop Industrial Pharm, 2009, 35: 83-97.

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  • 1徐宏山,刘欣玉,贾丽丽,董德梅,周蓉,孙明波,杨卉娟,杨会强,李玉华.首批人抗乙型脑炎病毒血清候选国家标准品的研制[J].微生物学免疫学进展,2022,50(6):15-19. 被引量:2
  • 2周铁群,陈震,王剑锋,英志芳,邱平,范行良,李娟,李长贵,方捍华,陈海平,李秀玲,谢芸,许丽锋,郭绍红,董春明,刘立新,罗耀兴,蔡汉港,张吉凯,徐宁,张铭驱,李建基.我国自行研制的冻干水痘减毒活疫苗的临床效果评价[J].中国生物制品学杂志,2005,18(4):342-345. 被引量:20
  • 3饶永彩,赵丽萍,杜碧琳.pH值对冻干乙脑活疫苗滴度的影响[J].中国生物制品学杂志,1995,8(4):174-174. 被引量:2
  • 4张道华,侯继波,何家惠,于漾,肖琦.鸡新城疫活疫苗耐热保护剂研究[J].中国家禽,2006,28(9):14-15. 被引量:2
  • 5Sakaguchi M, Miyazawa H, Inouye S. Specific IgE and IgG to gelatin in children with systemic cutaneous reactions to Japauese encephalitis vaccines [J] . Allergy,2001,56 (6) :536-539.
  • 6Swanson MC, Rosanoff E, Gurwith M, et al. IgE and IgG antibodies to beta-propiolactone and human serum albumin associated with urticarial reactions to rabies vaccine [J]. J Infect Dis, 1987,155 (5) :909-913.
  • 7Rottem M. Asthma prevalence and exacerbations in children: is there an association with childhood vaccination? [ J]. Expert Rev Clin Immunol, 2008, 4(6) :687- 694.
  • 8Fritsche P J, Helbling A, Ballmer-Weber BK. Vaccine hypersensitivity-update and overview [ J]. Swiss Med Wkly, 2010, 140( 17/18 ) :238-246.
  • 9张晋,张颖,杨阳,等.冻干乙型脑炎灭活疫苗(Vero细胞)非动物源性稳定剂的筛选[J].中国生物制晶学杂志,2009,22(11):1110-1112.
  • 10厄特延GW,黑斯利P.徐成海,彭润铃,刘军,等译冷冻干燥[M].北京:化学工业出版社,2005:281-351.

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