- 期刊
大型輸注液之熱原試驗
Pyrogen Test For Large Volume Parenteral Pharmaceuticals
摘要
大型輸注液(Large Volume Parenteral, LVP)是指以點滴靜脈注射100毫升以上之電解質、代用血漿、胺基酸、維他命等各種輸注液產品。主要用於體質虛弱或手術前後之病患，該產品若受到發熱性物質污染，則會直接危及病患之生命安全。因此為確保民眾用藥安全並提升醫藥品質，本計畫對於大型輸注液中維生素製劑及非新藥安全監視期間之學名藥製劑進行品質監測。本監測計畫，係採市售與源頭抽樣併行方式，委請各衛生局至轄區醫院、診所、藥房或直接至製藥廠執行抽樣，共取得抽樣檢體256件，其中國產檢體243件佔94.9%，輸入檢體13件佔5.1%，分別來自國內10家及國外5家藥廠。檢體容量有七種，分別為100mL、200mL、250mL、300mL、400mL、500mL及1000mL，檢體容器材質有玻璃瓶（72件）、塑膠瓶（127件）及塑膠軟袋（57件）共3種。熱原試驗方法係依據美國藥典第ⅩⅩⅦ版及中華藥典第五版，使用兔子作為實驗動物進行檢驗，結果顯示256件檢體均符合藥典熱原試驗之規定。然而有1件輸入檢體外盒並無中文標示，已函請原送驗衛生局或轄區衛生局依藥事法相關規定處辦。
並列摘要
Large Volume Parenteral (LVP) refers to injection of large volume of intravenous solution including electrolytes, substitute plasma, amino acids, and vitamins, etc. into patients recovering from surgery. Contamination with pyrogen would cause threat to the health of patients. The purpose of this study was to investigate the quality of LVP Pharmaceuticals in vitamin product and existing drug monitoring pyrogenic contamination, in order to ensue safety of the patients in Taiwan. A total of 256 samples were collected by the local health authorities from hospitals, clinics, pharmacies and manufacturers in 21 different counties. 243 samples (94.9%) were produced by local manufacturers (10 factories) and 13 (5.1%) were imported (5 factories). The volume of the samples was 100mL, 200mL, 300mL, 400mL, 500mL and 1000mL, respectively. Glass bottles (72 samples), plastic bottles (127 samples) and soft bags (57 samples) were used as containers. The pyrogen test was adopted from the US Pharmacopoeia ⅩⅩⅦ and the Chinese Pharmacopoeia Ⅴ, using rabbits as the laboratory recipients. The result showed that all samples met pyrogenic contamination guidelines. However one imported sample did not have Chinese labeling, and so was sent to the local health authority for penalty according to Pharmaceutical Affairs Act.