市售輸入第八凝血因子及第九凝血因子製劑之效價試驗調查

THE POTENCY OF ANTI-HEMOPHILIC FACTOR VIII AND FACTOR IX IN TAIWAN

為瞭解市售輸入凝血因子血液製劑之品質，於民國八十四年七月至八十五年六月間，由台灣地區該類藥品代理商處直接抽購檢體計10件，含第八凝血因子（Factor VIII）9件及第九凝血因子（Factor IX complex）1件。分別依原廠之方法做適當修正測定其凝血時間，並計算其相對效價。結果第八凝血因子及第九凝血因子效價均符合我國「生物製劑檢驗基準」之規定。

In order to evaluate the quality of imported antihemophilic factor VIII and factor IX in Taiwan, potency tests were conducted on nine samples of factor VIII and one sample of factor IX purchased randomly from the Taiwan representative of 10 overseas manufacturers between July 1995 and June 1996. All these samples were assayed according to the analytical protocols provided by the manufacture's with some modifications. All the samples met the Minimum Requirements of Biological Standard.