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目的 应用Vero细胞研制人用精制狂犬病疫苗。方法应用Vero细胞经转瓶或生物反应器培养制备人用精制江大病疫苗。结果各项质控指标均符合WHO和中国生物制品规程标准,经I期临床观察疫苗是安全的。结论用Vero细胞生产的狂犬病疫苗产量大,效价高,不良反应少,且能进行工业化生产。
Objective To develop human rabies vaccine with Vero cells. Methods Vero cells were cultured by spinner flask or bioreactor to prepare purified Jiang disease vaccine for human. Results The quality control indicators were in line with the WHO and China Biological Products Regulations standards, the Phase I clinical observation of the vaccine is safe. Conclusion The rabies vaccine produced by Vero cells has high yield, high potency and few adverse reactions, and can be used in industrial production.