三種輸入生物製劑之效價調查

AN INVESTIGATION ON POTENCY OF IMPORTED BIOLOGICAL PREPARATIONS

目前輸入生物製劑品除於申請查驗登記時曾予以檢驗，此後進口不似國產製劑須逐批封緘檢驗，故其效價品質是否符合規定，實有檢驗調查的必要。因此於民國75年8月～12月於台灣地區抽購輸入之抗破傷風免疫球蛋白12件，口服小兒麻痺疫苗4件，麻疹疫苗6件，共22件，依據衛生署公佈之生物製劑檢驗基準的方法，測定其效價以評估其品質。

In order to understand the quality of imported biological preparations in Taiwan Area, 22 samples were gathered randomly from different countries and cities of Taiwan. All methods on Potency test were according to 'Inspective Regulation on Biological Preparations' that unnounced by Hygiene Dept. In this test, Only 21 samples (Ca. 95. 4%), Included oral polio vaccine 3 (Ca. 75%) in 4 samples, measles vaccine 6 (Ca. 100%) in 6 samples, and Anti-Tetanus Immunoglobulin 12 (Ca. 100%) in 12 samples were met the potency requirement of the government regulations.