流行性感冒裂解疫苗的研制

作为换代产品,流行性感冒裂解疫苗的研制已取得突破性进展,根据WHO有关规程的规定和大量的试验研究结果。完整建立了该疫苗的生产工艺和生产质量控制系统,完成了“流行性感冒裂解疫苗制造及检定规程”等规定性文件的起草和审核工作,以中试规模连续生产了三批疫苗并全部自检合格,通过疫苗稳定性试验,效力试验,异常毒性试验及过敏性试验等观察。进一步肯定了疫苗的质量。

Preparation of splited influenza virus vaccine

The manufacturing technics and quality control about preparation of splited influenza virus vaccine are based on our experimental results and requirements of biological products of world health organization.The procedural documents such as"The rules for manufacture and control tests of splited influenza virus vaccine"have been completed.According to the rules,three batchs of qualified vaccines have been made in a middle scale,all tests results are in conformation with the requirements.The disired results have been obtained including stability,the potency,the exceptional toxicity and allergic test for vaccine.The quality of this vaccine is further confirmed.