流行性感冒病毒裂解疫苗的研制和质量控制

Preparation and quality control of split influenza virus vaccine

[目的 ] 研制新型的流行性感冒病毒裂解疫苗 ,并评价其免疫效果。 [方法 ] 利用乙醚裂解流行性感冒病毒 ,制得该疫苗。 [结果 ] 三批流行性感冒病毒裂解疫苗经中国药品生物制品检定所检定合格 ,并通过临床考核 ,取得令人满意的免疫效果。 [结论 ] 该疫苗具有良好的安全性和免疫原性。

To develop split influenza virus vaccine and evaluate its immunological effect. Using ether to spilt influenza virus to produce this vaccine. Three batches of split influenza virus vaccine had passed the tests given by the National Institute of Control of Pharmaceutical and Biological Products.Besides,these vaccine had passed clinical trial with satisfactory immunological effect. [Conclusion] The study showed that this newly prepared vaccine had a desirable safety and immunogenicity.