Gupta R K, Sharma S B, Ahuja S, Saxena S N
Vaccine. 1986 Sep;4(3):185-90. doi: 10.1016/0264-410x(86)90008-3.
Plain pertussis vaccine manufactured with different inactivating agents was evaluated for its stability at 4-8, 25 and 35 degrees C with regard to the opacity and the toxicity [mouse weight gain test (MWGT) and histamine sensitizing (HS) activity]. Two pools each of heat inactivated pertussis vaccine (HIPV), formaldehyde inactivated pertussis vaccine (FIPV), glutaraldehyde inactivated pertussis vaccine (GIPV), thimerosal inactivated pertussis vaccine (TIPV) and acetone (I) treated pertussis vaccine [A(I)TPV] were taken for the study. The test for determination of opacity and MWGT were performed at monthly intervals for three months and the test for HS activity was performed after three months exposure of the samples at various temperatures. There was almost no loss in the opacity of GIPV and TIPV at all the selected storage temperatures and of HIPV and FIPV at 4-8 degrees C, while A(I)TPV lost about 16% opacity in three months at 4-8 degrees C. At 25 degrees C after three months, the percentage loss in opacity of HIPV averaged about 12, of FIPV 17 and of A(I)TPV 33. At 35 degrees C after three months, the average percentage loss in opacity of HIPV was 16, of FIPV was 25 and of A(I)TPV was 33. Regarding the effect of elevated temperatures on the toxicity of the vaccine, it was observed that the samples held at 35 degrees C for three months were the least toxic followed by those held at 25 and 4-8 degrees C as detected by MWGT and the test for HS activity.
对用不同灭活剂生产的普通百日咳疫苗，就其在4 - 8℃、25℃和35℃下的不透明度及毒性[小鼠体重增加试验（MWGT）和组胺致敏（HS）活性]进行了稳定性评估。选取了热灭活百日咳疫苗（HIPV）、甲醛灭活百日咳疫苗（FIPV）、戊二醛灭活百日咳疫苗（GIPV）、硫柳汞灭活百日咳疫苗（TIPV）和丙酮（I）处理的百日咳疫苗[A（I）TPV]各两个批次进行研究。不透明度测定试验和MWGT每三个月进行一次，共进行三个月，HS活性试验在样品于不同温度下存放三个月后进行。在所有选定的储存温度下，GIPV和TIPV的不透明度几乎没有损失，4 - 8℃下的HIPV和FIPV也是如此，而A（I）TPV在4 - 8℃下三个月内不透明度损失约16%。三个月后在25℃时，HIPV不透明度的损失百分比平均约为12，FIPV为17，A（I）TPV为33。三个月后在35℃时，HIPV不透明度的平均损失百分比为16，FIPV为25，A（I）TPV为33。关于温度升高对疫苗毒性的影响，观察到通过MWGT和HS活性试验检测，在35℃下存放三个月的样品毒性最小，其次是在25℃和4 - 8℃下存放的样品。
