101至103年度血液製劑檢驗封緘案件分析

Analyzing Batch Release of Blood Products in Taiwan, 2012-2014

謝郁琦(YU-CHI HSIEH)；杜慧珍(HUEY-JEN DUH)；葉美伶(MEI-LING YEH)；林佳蓓(CHIA-PEI LIN)；何明純(MING-CHUN HO)；柳逸照(YI-CHAO LIU)；楊依珍(YI-CHEN YANG)；陳惠芳(HWEI-FANG CHENG)

血液製劑 ； 檢驗封緘 ； blood product ； batch release

食品藥物研究年報

6期（2015 / 12 / 01）

173 - 181

繁體中文

本報告係食品藥物管理署(以下稱食藥署)101至103年度執行生物藥品中血液製劑檢驗封緘案件之統計分析，以了解國人使用之血液製劑整體需求概況，並藉此確認各血液製劑品質均能符合中華藥典或原廠之規範。101至103年度放行血液製劑檢驗封緘產品共370批，經現場查核儲運溫度並抽樣檢體後，已完成檢驗總計放行2,911,495瓶，經逐批進行檢驗與審查，結果均符合中華藥典或原廠規範，合格率100%，並核發封緘證明書，供國人用於治療或預防相關疾病。而血液製劑主要可分為四大類，白蛋白注射劑、免疫球蛋白注射劑、凝血因子注射劑及纖維蛋白止血組；統計101至103年度申請檢驗封緘之批數及總數量最多者均為白蛋白注射劑；在國血製劑方面，總計其檢驗封緘放行數量為31批347,041瓶，佔總數量11.9%。透過統計分析及探討，使國人更了解近三年度常用血液製劑之放行狀況，以供未來用藥及相關政策擬定之參考。

This report presents the investigation of the annual batch release of imported blood products from 2012 to 2014. We evaluated a total of 370 batches, which included a total of 2,911,495 bottles. All of the results complied with the specifications listed in the Chinese pharmacopeia, as well as in other regulations. Our tests indicated that the blood products collected contained items such as albumin injection, immunoglobulin, coagulation factor, and fibrin sealant set. In this study, the top batches and the highest quantities of blood products were Albumin. We also tested for intravenous immunoglobulin, albumin, high purity factor VIII concentrate, and high purity factor IX concentrate, which were prepared from human plasma, and were obtained from voluntary blood donors in Taiwan. In conclusion, all of the products tested have met quality, safety and efficacy requirements.