Gupta R K, Sharma S B, Ahuja S, Saxena S N
J Biol Stand. 1987 Jan;15(1):87-98. doi: 10.1016/0092-1157(87)90020-5.
The effect of heat (56 degrees C for 10 min), formaldehyde (0.1% at 37 degrees for 24h), glutaraldehyde (0.05% at room temperature for 10 min), thimerosal (0.02% at 37 degrees C for 24h), acetone-I (three treatments at room temperature) and acetone-II (three treatments at room temperature and fourth treatment at 37 degrees C), when used as inactivating agents in the preparation of pertussis suspension, was studied with regard to potency, toxicity and stability. Five batches each of Bordetella pertussis strains 134 and 509 were used for the study. The thimerosal inactivated pertussis (TIP) preparation was 1.5-2 times more potent than the heat inactivated pertussis (HIP) preparation. The potency values of the formaldehyde inactivated pertussis (TIP) and glutaraldehyde inactivated pertussis (GIP) preparations were similar to those of the HIP preparation, while the potencies of the acetone-I treated pertussis (A(I)TP) and acetone-II treated pertussis (A(II)TP) preparations were about half those of the HIP preparation. The FIP preparation was the least toxic showing maximum weight gain in the mouse weight-gain test (MGWT), while the TIP preparation did not pass the MWGT. The weight gains shown the GIP, A(I)TP and A(II)TP preparations were greater than those shown by the HIP preparation. The potency of pertussis component in the adsorbed diphtheria-pertussis-tetanus (DPT) vaccine was stable at 4-8 degrees C and 25 degrees C for three months for all types of pertussis vaccine. There was about 54-65% loss in the potency of the samples after three months at 35 degrees C. The inactivating agents used in the manufacture of pertussis preparations had no effect on the stability of the vaccine.
研究了热（56摄氏度，10分钟）、甲醛（0.1%，37摄氏度，24小时）、戊二醛（0.05%，室温，10分钟）、硫柳汞（0.02%，37摄氏度，24小时）、丙酮-I（室温下处理三次）和丙酮-II（室温下处理三次，第四次处理在37摄氏度）作为百日咳悬液制备中的灭活剂时，对效力、毒性和稳定性的影响。使用了百日咳杆菌菌株134和509各五批进行研究。硫柳汞灭活百日咳（TIP）制剂的效力比热灭活百日咳（HIP）制剂高1.5至2倍。甲醛灭活百日咳（FIP）制剂和戊二醛灭活百日咳（GIP）制剂的效力值与HIP制剂相似，而丙酮-I处理的百日咳（A(I)TP）制剂和丙酮-II处理的百日咳（A(II)TP）制剂的效力约为HIP制剂的一半。FIP制剂毒性最小，在小鼠增重试验（MGWT）中体重增加最大，而TIP制剂未通过MWGT。GIP、A(I)TP和A(II)TP制剂的体重增加大于HIP制剂。对于所有类型的百日咳疫苗，吸附白喉-百日咳-破伤风（DPT）疫苗中百日咳成分的效力在4至8摄氏度和25摄氏度下可稳定三个月。在35摄氏度下放置三个月后，样品的效力损失约54%至65%。百日咳制剂生产中使用的灭活剂对疫苗的稳定性没有影响。
