Gupta R K, Saxena S N, Sharma S B, Ahuja S
Biological Standardization and Quality Control Division, Central Research Institute, Kasauli, India.
Vaccine. 1988 Dec;6(6):491-6. doi: 10.1016/0264-410x(88)90099-0.
The optimal conditions for inactivation of Bordetella pertussis organisms with glutaraldehyde for the production of a safe and potent whole cell pertussis vaccine were investigated. Two bacterial harvests from B. pertussis strain 10536 were treated with glutaraldehyde, each with 0.025, 0.05 and 0.1% concentrations of glutaraldehyde for 10, 60 and 120 min. The nine types of glutaraldehyde-inactivated pertussis vaccine (GIPV) and conventional heat-inactivated pertussis vaccine (HIPV) preparations made from two bacterial harvests were comparatively evaluated for the mouse weight gain test (MWGT), potency, and the histamine-sensitization (HS) and leucocytosis-promoting-factor (LPF) tests. The minimum period for killing the B. pertussis organisms with glutaraldehyde was greater than 10 min for 0.025%, 10 min for 0.05% and 5 min for 0.1% concentration. The average loss in opacity varied from 5 to 10% for GIPV preparations and was 14% for HIPV preparations. The GIPV preparations except those inactivated with 0.025% glutaraldehyde for 10 min (GIPV-A) were much less toxic than the HIPV preparations in the MWGT. The GIPV-A preparations did not pass the MWGT. The GIPV preparations were also much less toxic in HS and LPF tests than the HIPV preparation. The potency of GIPV preparations inactivated with 0.05% glutaraldehyde for 10 min (GIPV-D) was similar to that of HIPV preparations. The prolonged treatments with glutaraldehyde reduced the potency. The GIPV-D preparation with good potency and less toxicity was found to be inactivated with glutaraldehyde under optimal conditions. All the preparations were innocuous in the abnormal toxicity test.
研究了用戊二醛灭活百日咳博德特氏菌以生产安全有效的全细胞百日咳疫苗的最佳条件。从百日咳博德特氏菌10536菌株收获的两批细菌用戊二醛处理，每批分别用浓度为0.025%、0.05%和0.1%的戊二醛处理10、60和120分钟。对由两批细菌制成的九种戊二醛灭活百日咳疫苗（GIPV）和传统热灭活百日咳疫苗（HIPV）制剂进行了小鼠体重增加试验（MWGT）、效力以及组胺致敏（HS）和白细胞增多促进因子（LPF）试验的比较评估。用戊二醛杀死百日咳博德特氏菌的最短时间，0.025%浓度大于10分钟，0.05%浓度为10分钟，0.1%浓度为5分钟。GIPV制剂的平均浊度损失为5%至10%，HIPV制剂为14%。除用0.025%戊二醛处理10分钟的制剂（GIPV-A）外，GIPV制剂在MWGT中的毒性比HIPV制剂小得多。GIPV-A制剂未通过MWGT。GIPV制剂在HS和LPF试验中的毒性也比HIPV制剂小得多。用0.05%戊二醛处理10分钟的GIPV制剂（GIPV-D）的效力与HIPV制剂相似。延长戊二醛处理时间会降低效力。发现效力良好且毒性较小的GIPV-D制剂是在最佳条件下用戊二醛灭活的。所有制剂在异常毒性试验中均无毒。
