两种不同保护剂冻干的仔猪副伤寒活疫苗质量比较

发布时间：2018-04-12 12:40

本文选题：仔猪副伤寒活疫苗 + 同类产品　；参考：《微生物学通报》2017年09期

【摘要】：【目的】系统比较两种不同保护剂冻干的仔猪副伤寒活疫苗(耐热苗和常规苗)质量指标,为科学评价两种疫苗质量提供参考。【方法】制备耐热苗和常规苗各3批,分别进行物理性状、纯粹性、活菌计数、安全性、剩余水分、真空度和保存期等参数测定和比较,同时比较冻干前后的活菌存活率及耐老化性能。任选耐热苗与常规苗1批,按3×109 CFU分别口服与肌肉注射仔猪各5头,设相同条件下不免疫对照5头,30 d后静脉注射致死量猪霍乱沙门氏菌,临床观察30 d后评估疫苗的效力。【结果】耐热苗及常规苗的物理性状、纯粹性、活菌计数、安全性、剩余水分、真空度均符合现行《中国兽药典》的要求。3批耐热苗冻干菌存活率分别为88.2%、83.1%和86.4%,耐老化试验后的活菌存活率为83.6%、82.9%和88.8%;然而3批常规苗冻干菌存活率分别为52.3%、56.2%和61.4%,耐老化活菌存活率分别为58.5%、60.2%和54.7%。经37°C、7 d耐老化试验结果显示,耐热苗物理性状良好,而常规苗原有团块表面凹陷1/4-1/2。保存期结果表明耐热苗4°C有效期可达24个月,常规苗仅为9个月。仔猪免疫攻毒结果表明,耐热苗肌肉注射及口服免疫均达100%(5/5)保护;常规苗肌肉注射达80%(4/5)保护,口服达100%(5/5)保护,不免疫对照0保护(5/5死亡)。【结论】耐热苗具有较高的冻干菌存活率和良好的耐老化性能,4°C可长期保存且不影响其免疫效力。
[Abstract]:[objective] to compare the quality indexes of two kinds of lyophilized porcine paratyphoid vaccine (heat-resistant vaccine and conventional vaccine) systematically, and to provide a reference for the scientific evaluation of the quality of the two vaccines. [methods] three batches of heat-resistant vaccine and three batches of conventional vaccine were prepared.The physical properties, purity, living bacteria count, safety, residual moisture, vacuum degree and storage life were measured and compared respectively, and the survival rate and aging resistance of live bacteria before and after freeze-drying were compared.5 piglets were injected orally and intramuscularly at 3 脳 10 ~ 9 CFU, and 5 pigs were injected intravenously under the same conditions. Salmonella cholerae was injected intravenously after 30 days.The efficacy of the vaccine was evaluated after 30 days of clinical observation. [results] the physical properties, purity, live bacteria count, safety, residual moisture of heat-resistant vaccine and conventional vaccine were evaluated.The survival rate of aging resistant live bacteria was 60.2% and 54.7%, respectively.The results of 37 掳C ~ + 7 d aging test showed that the heat-resistant seedlings had good physical properties, while the surface of the original mass of conventional seedlings was 1 / 4 / 1 / 2 / 2.The results of preservation period showed that 4 掳C of heat-resistant seedlings could be valid for 24 months, and that of conventional seedlings was only 9 months.The results of immunization against virus in piglets showed that heat resistant vaccine injection and oral immunization were 100 / 5 / 5) protection; conventional vaccine intramuscular injection was 80% / 5 / 5) protection, oral dose 100% 5 / 5) protection.[conclusion] Heat-resistant vaccine has high survival rate of freeze-dried bacteria and good aging resistance (4 掳C). It can be preserved for a long time and does not affect its immune potency.
【作者单位】：中国兽医药品监察所;北京中海生物科技公司;山东农业大学动物科技学院;
【基金】：国家重点研发计划项目(No.2016YFD0500902) 北京市科委企业提升计划项目(No.Z121102002812080)~~
【分类号】：S859.797

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