破傷風生物製劑之力價試驗

POTENCY TEST ON THE TETANUS PREPARATIONS IN TAIWAN AREA

台灣地區目前市面上之生物製劑中，含破傷風類製劑所佔比例頗大。為了解目前市售此種產品品質概況，作此調查。因此於74年7月～75年6月於台灣地區普遍抽購國產及輸入含破傷風生物製劑22件（包括明礬沈澱破傷風類毒素7件，吸著白喉、破傷風、百日咳混合疫苗5件、破傷風抗毒素7件、破傷風免疫球蛋白3件），依據衛生署公告生物製劑檢驗基準之方法（P.14-15，18-19，31-32，32）測定其效價以評估品質。

22 Tetanus Preparations were gathered from different countries and cities of Taiwan. Among them, 14 samples were domestic and 8 samples were imported. All methods on potency test were accroding to 'Inspective Regulation on Biological Preparations' that unnounced by Hygiene Dept. In this test, 1 of imported sample was unpassed the potency test, because its expire dates was over. If this sample case was routed out, then all other samples, both of domestic and imported, were entirely met the potency reguirement of the government regulation (Ca. 100%).