OPV疫苗糖丸在-20℃以下保存的稳定性

STABILITIES OF LIVE ATTENUATED ORAL POLIOMYELITIS VACCINE BALLS STORED UNDER-20℃.

目的：考察口服脊髓灰质炎减毒活疫苗糖丸（OPV）在-20℃温度下保存的稳定性.方法：将存放在-20℃以下1999～2003年生产的疫苗糖丸样品各随机抽取10个批号,分别进行3价总病毒含量及Ⅰ、Ⅱ、Ⅲ型分型病毒含量检测,根据检测结果,分析糖丸存放于-20℃以下1～5年其病毒含量及其变化.结果：糖丸存放于-20℃以下2年,其3价总病毒含量及Ⅰ、Ⅱ、Ⅲ型分型病毒含量4个指标均达到2000年版《中国生物制品规程》的要求;-20℃以下保存5年,3价总病毒含量及Ⅰ、Ⅱ、Ⅲ型分型病毒含量（log CCID50/粒）平均值分别为5.59±0.12、5.57±0.08、5.02±0.24及4.85±0.29;在3个型中,Ⅲ型病毒含量下降值最多,Ⅰ型次之,Ⅱ型最少（P＜0.01）.结论：口服脊髓灰质炎减毒活疫苗糖丸存放于-20℃以下1～5年的稳定性良好.

Objective： To detect the stabilities of live attenuated oral poliomyelitis vaccine balls stored under - 20℃. Methods： Ten lots of vaccine stored under - 20℃ from 1999 to 2003 were randomly selected and were detected for total and separate viral titers of each ball for type Ⅰ, Ⅱ, Ⅲ virus, respectively.Results： The total and separate LogCCID50/ball for type Ⅰ, Ⅱ and Ⅲ virus stored under -20℃; for 2 years met the requirment of ＂Requirements for Biological Products＂ . Stored under -20℃ for 5 years, average value of total viral titer was 5.59 ± 0.12 LogCCID50, and average value of separate viral titers were 5.57 ± 0.08 , 5.02 ± 0.24 and 4.85 ± 0.29 LogCCID50 for type Ⅰ, Ⅱ and Ⅲ virus respectively. The results showed that type Ⅱ virus was most stable, but the titer of type Ⅲ virus decreased obviously.Concluslon： Live attenuated oral poliomyelitis vaccine showed good stability stored under - 20℃.