吸著白喉、破傷風、百日咳混合疫苗是我國防疫接種上重要疫苗之一,而毒性試驗是反映本疫苗品質安全性的重要試驗。在民國79年6月至84年6月共五年度間,吸著白喉、破傷風、百日咳混合疫苗共35批次,隸屬歐美三家製造廠進行檢驗封緘。其中有4批次疫苗異常毒性試驗之豚鼠試驗部份被判定為不適。毒性試驗中各項試驗結果顯示,各製造廠間除百日咳疫苗小白鼠毒性試驗之注射後第七日平均增重率有顯著差異外,其他各項試驗之增重率及症狀並無顯著差異。
DPT vaccine is one of the most important vaccines used in the immunization program of Taiwan. Toxicity tests are believed to reflect the safety of DPT vaccine. A total of 35 batches of DPT vaccine were subjected to toxicity testing by the minimum requirements for biological prducts. Among them, 4 batches failed the abnormal toxicity test upon the inoculation of guinea pigs. The average animal weight-gain profile for all tests are discussed in the text.