102年度血液製劑檢驗封緘案件分析

Results of Annul Surveillance of Batch Release: Blood Products in Taiwan, 2013

謝郁琦(Yu-Chi Hsieh) ； 林憶薰(Yi-Hsun Lin) ； 林育如(Yu-Ju Lin) ； 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) ； 王德原(Der-Yuan Wang) ； 施養志(Yang Chih Shih) ； 陳惠芳(Hwei-Fang Cheng)

《食品藥物研究年報》 5期 (2014/12) Pp. 174-182

摘要

本報告係本署102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品質概況，並確認各血液製劑品質均能符合中華藥典或原廠之規範。102年度放行血液製劑檢驗封緘產品共134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988,939瓶，經逐批進行19項1,391次之檢驗與審查，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，始得供國人施用以治療或預防相關疾病。102年度放行之134批產品中，128批血液製劑分別來自9間藥商所持有之34張許可證，其餘6批產品係疾病管制署為因應102年突發的狂犬病疫情，申請專案進口之狂犬病免疫球蛋白。統計102年度申請檢驗封緘之批數前3名依序為血清白蛋白、纖維蛋白止血組及B肝免疫球蛋白，總數量前3名則為血清白蛋白、免疫球蛋白靜脈注射劑及B肝免疫球蛋白；在國血製劑方面，其檢驗封緘放行數量為12批105,434瓶，佔總量10.7%。

關鍵字

血液製劑 ； 檢驗封緘

並列摘要

This report presents results from a batch release of imported blood products during the period of January 1^(st) to December 31^(st) 2013. In order to evaluate 134 batches, which included a total of 988,939 bottles, 19 items and 1,391 tests were conducted. All of the results complied with the specifications listed in Chinese pharmacopeia and in other regulations. Among these 134 batches, 128 batches belong to 34 licensed products, while the 6 unlicensed batches are Rabies immunoglobulin which had been imported by Centers of Disease Control for preventing Rabies infection. In summary, the top three batches of blood products were Albumin, Fibrin sealant set, and Hepatitis B immunoglobulin, respectively, and the three highest quantities of blood products were Albumin, Intravenous immunoglobulin and Hepatitis B immunoglobulin, respectively. In addition, there were 38,824 bottles of intravenous immunoglobulin, 53,154 bottles of albumin, 3,667 bottles of high purity factor IX concentrate, and 9,789 bottles of high purity factor VIII concentrate, all of which were prepared from human plasma obtained from voluntary blood donors in Taiwan.

並列關鍵字

blood product ； batch release