乙型肝炎卡介苗联合疫苗稳定性的研究

Stability of Hepatitis B-BBG Combined Vaccine

研究乙型肝炎卡介苗联合疫苗中乙肝病毒表面抗原(HBsAg)组分的稳定性。将连续3批联合疫苗,分别放置于37、25、4℃三种温度条件下,并于1、2、3、6、12、18、24个月时间取样检测,采用ELISA方法检测HBsAg含量,研究不同条件下联合疫苗中HBsAg的变化和HBsAg组分的免疫原性。37、25℃条件下6个月,4℃条件下2a,HBsAg组份含量无明显变化,均在合格范围内。37℃放置1、6个月,4℃条件下放置2a的联合疫苗免疫豚鼠,HBsAg组分的免疫原性无明显变化。乙型肝炎卡介苗联合疫苗中HBsAg组分的稳定性良好,4℃条件下放置2a效力无明显下降。

Three lots of hepatitis B-BBG combined vaccines were stored in 37, 25 and 4 ℃ and sampled at 1, 2, 3, 6, 12, 18, 24 months＇storage for testing and measurement of their HBsAg contents with ELISA respectively to study the changes of HBsAg and the immunogenicity of HBsAg＇s components in different conditions. The results showed that under 37 ℃ and 25 ℃ stored for 6 months, 4 ℃ stored for 2 years no obvious changes in HBsAg components, they were within qualified range. And guinea pigs vaccinated with combined vaccine under 37 ℃ stored for 6 months and under 4 ℃ stored for 2 years, there were no apparent immunogenicity changes in HBsAg components. Therefore, the stability of HBsAg in hepatitis B-BBG combined vaccine was good, and there were no obvious changes of its effects stored under 4 ℃ for 2 years.