摘要
血液透析的目的主要在排除病人腎功能不全而引起之併發症，可藉著體外血液循環方式，利用人造半透膜的擴散作用與病人血液作離子交換，將血液中有毒之代謝物排出體外，以獲得淨化之血液，故其品質必須嚴格控管以確保洗腎病人之安全。本計劃之檢體來源係由北、高兩市及台灣地區20個縣市地方衛生單位至所管轄之醫院、診所及洗腎中心抽取血液透析液之檢體，檢體總件數為44件，其中國產檢體有23件(52.2%)，輸入檢體有21件(47.8%)。血液透析液之品質調查檢驗項目係依85.09.17衛署藥字第85053134號公告進行熱原試驗、細菌內毒素試驗及微生物限量試驗，試驗方法係分別依據英國藥典2000、歐洲藥典2000及中華藥典第四版之規格進行檢驗。本實驗檢驗之44件檢體，其檢驗結果均合格，符合衛生署公告之規定。
並列摘要
Blood dialysate is used on patients with kidney dysfunction. The patient's blood is processed with the in vitro circulating dialysis system to exclude the toxic metabolites by diffusion effect from their bodies through dialytic membrane. Therefore, the quality of hemodialysis solution is important to patient's safety. In this study, forty-four samples were collected from local hospitals, clinics, and dialysis centers in 23 counties and cities in Taiwan area. Twenty-three (52.2%) of these samples were produced by local manufactures and the others (47.8%) were imported. The categories oftesting the hemodialysis solution quality, including pyrogen test, bacterial endotoxins test and microbial contamination test, were based on the notification No.85053134 from Department of Health. All testing methods used in this evaluation were based on the British Pharmacopoeia 2000, the European Pharmacopoeia 2000, and the Chinese Pharmacopoeia Ⅳ. The results showed that all of the samples were qualified. This suggested that the hemodialysis solution products used in Taiwan are safe and conformable to the DOH guidance.