血源乙型肝炎疫苗的效力稳定性试验研究

Research on the Stability of the Potency of the Hepatitis B Vaccine Prepared from Plasma

对保存温度分别为３７℃、２－８℃、１８－２２℃，保存时间分别为１年、１．５年、２．５年的血源乙型肝炎疫苗进行了效力稳定性试验。结果表明，３７℃保存４周经效力测试已无活性存在，而２－８℃、１８－２２℃保存１年、１．５年、２．５年的疫苗经效力试验测定，２－８℃试ＥＤ５０／参ＥＤ５０比值可达１．０５－２．７４，２．５年后比值仍可达１．０５－１．６７，保持在合格限以上。但１８－２２℃试ＥＤ５０／参ＥＤ５０比值为０．７８－１．５２，其活性已下降。试验结果表明血源乙型肝炎疫苗在２－８℃保存的疫苗稳定性良好，其有效期至少在２．５年以上。

The stability tests for the potency of the Hepatitis B Vaccine prepared from plasma were performed.The samples were stored at 37℃,2-8℃ and 18-22℃ for 1,1.5,and 2.5 years respectively before testing.The results showed:1)the samples had had no activities after 4 weeks kept at 37℃;2)the ratioes of ED50 of the samples stored at 2-8℃ for 1,1.5 and 2.5 years to the reference were 1.05-2.74,and meet the requirements;3)the ratio of ED50 of the samples stored at 18-22℃ for 1,1.5 and 2.5 years to the reference was 0.78-1.52,and the activities of the samples have decreased.It shows that the stability of the Hepatitis B Vaccine stored at 2-8℃ is good,and the shelf life could be more than 2.5 years.