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| 沙门氏菌类活疫苗活菌计数参考疫苗的研究 |
| 王秀丽,蒋玉文,张媛,李红霞,袁露,李爱玲,曹翠萍,刘博,辛凌翔,彭国瑞,李建 |
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| (中国兽医药品监察所 北京 100081) |
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| 摘要: |
| 本研究试图研制沙门氏菌类活疫苗活菌计数的参考疫苗，以期更科学的评价活菌计数结果的有效性。制备一批仔猪副伤寒活疫苗作为参考疫苗候选物，对其性状、纯粹检验、真空度、剩余水分进行检测，对其运输稳定性、均一性进行测定，组织协作标定对参考疫苗进行赋值，用协作标定的方法统计参考疫苗候选物在18个月的保存期，将参考疫苗初步应用于仔猪副伤寒活疫苗活菌计数的检验中。结果表明，参考疫苗的性状、纯粹检验、剩余水分和真空度测定均符合《中国兽药典》的规定，均一性试验结果显示，10瓶参考疫苗候选物计数结果的变异系数小于10%，说明参考疫苗均一性良好。协作标定统计出参考疫苗的赋值范围为（3.0，4.0）×109CFU/头份，保存期试验结果显示参考疫苗候选物在-70℃以下保存18个月菌数稳定。参考疫苗的初步应用显示本参考疫苗不仅可以为沙门氏菌类活疫苗活菌计数提供参照物，而且可以用于控制普通琼脂培养基的质量。 |
| 关键词: 参考疫苗，活菌计数，沙门氏菌疫苗 |
| DOI： |
| 投稿时间：2018-12-28修订日期：2019-03-06 |
| 基金项目: |
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| Study on Reference Vaccine for Bacterial Plate |
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| (China Institute of Veterinary Drug Control Beijing 100081) |
| Abstract: |
| A batch of paratyphus live vaccines for piglets was produced as the candidate for the bacterial plate count reference vaccine on salmonella vaccines，in order to evaluate the test result of the bacterial plate count more scientifically. The parameters of characteristic, purity, vacuum degree, moisture were tested. The transport stability and uniformity were also tested. The live bacterium of candidates were statistical calculated by the value of collaboration calibration. The storage test in 18 months was carried out the same way as collaboration calibration. Then the candidates were used in the bacterial plate count test of paratyphus live vaccines for piglets. The study results showed that the candidates’ characteristic, purity, vacuum degree, moisture were up to the specification of Chinese Veterinary Pharmacopoeia. The uniformity test results showed that the coefficient variation of the 10 samples were less than 10%, showing a good uniformity. The live bacterium of candidates were (3.0,4.0) ×109CFU/dose. The storage test showed that the candidates were stable when they were stored at lower than -70℃ for 18 months. The preliminary application showed that the reference vaccines can be used not only in the control of the quality of normal agar medium, but also in the control of the test process of bacterial plate count of salmonella vaccines. |
| Key words: reference vaccines, bacterial plate count, Salmonella vaccine. |
