流感亚单位疫苗裂解剂残留量检测及安全性试验

目的检测流感亚单位疫苗的裂解剂残留量,并观察其安全性。方法制备3批流感亚单位疫苗,采用比色法检测其裂解剂Tween-80和CTAB的残留量,通过动物实验观察其安全性。结果制备的3批疫苗样品,Tween-80的残留量平均在68.3~72.0μg/ml之间,CTAB残留量平均在36.3~38.7μg/ml之间。在安全性试验中,豚鼠未出现过敏反应,小鼠和豚鼠未出现异常毒性反应。结论制备的流感亚单位疫苗的裂解剂残留量符合拟定规程要求,安全性良好。

Residual Lysing Agent Content and Safety of Influenza Virus Subunit Vaccine

Objective To determine the residual lysing agent content and safety of influenza virus subunit vaccine.Methods Prepare 3 batches of influenza virus subunit vaccine and determine the residual contents of lysing agents Tween-80 and CTAB in the vaccine by colorinetric method.Observe the safety of vaccine by animal test.Results The mean residual contents of Tween-80 and CTAB in the 3 batches of vaccine were 68.3～72.0 and 36.3～38.7 μg/ml respecively.No anaphylactic reaction was observed in guinea pigs,and no abnormal toxicity in mice or guinea pigs. Conclusion The residual lysing agent content in the prepared influenza virus subunit vaccine met the relevant requirements,and the vaccine showed good safety.