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目的 制备森林脑炎纯化疫苗。方法 将森林脑炎病毒感染地鼠肾单层细胞,收获病毒液,经超滤浓缩、柱层析纯化病毒后配制而成。结果 疫苗兔疫保护力指数均≥1 .0 ×106,杂蛋白去除率≥99%,小牛血清蛋白去除率>99%,所有检测项目全部合格。结论 该纯化工艺制备的森林脑炎纯化疫苗抗原含量高,热稳定性好,免疫原性强,各项检测结果均符合2000年版《中国生物制品规程》标准。
Objective To prepare purified forest encephalitis vaccine. Methods Encephalitis virus infected hamster kidney monolayer cells, harvested virus solution, concentrated by ultrafiltration, purified by column chromatography after the preparation of the virus. Results The protective index of rabies vaccine was ≥1. 0 × 106, the removal rate of mixed protein was ≥99%, and the removal rate of bovine serum albumin was> 99%. All the test items were qualified. Conclusion The purified encephalitis vaccine purified by this purification process has high antigen content, good thermal stability and strong immunogenicity. All the test results are in accordance with the 2000 edition of the “China Biological Products Regulations”.