文章詳目資料
藥物食品檢驗局調查研究年報
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中文摘要
本計畫之目的係調查台灣省北部地區各藥局所販賣之生理食鹽水（大型 輸注液）注射液，是否含有發熱性物質，總共抽取檢體36件，共由7家國内製 造廠所製造，檢體包裝則有4種，包括500 mL的玻璃瓶、塑膠瓶、軟袋裝及 1000 mL的塑膠瓶裝。熱原試驗方法係依據中華藥典第四版，使用兔子作為 實驗動物，其檢驗結果顯示所有兔子體溫上升之度數皆甚低（< 0.3 °C )，顯 示受試檢體皆不含熱原，合格率為百分之百，因此得知目前市售之國產生理 食鹽水製劑其品質在熱原方面可謂符合規定。
英文摘要
The purpose of this project was to survey for the presence of pyrogen in the products of normal saline in large commercial packages.Samples were collected from commercial drug stores in several towns and cities in northern Taiwan. In all 36 samples were collected and represented products manufactured by 7 companies in Taiwan. Four different packaging materials were used for containers. These included glass, plastic bottles and soft bags of 500 mL and plastic bottles of 1000 mL. The method of pyrogen testing was adapted from the Chinese Pharmacopoeia, 4th edition, using rabbits as the laboratory recipients. The results show that the average rise in body temperature was low (< 3(C) indicating that all products tested ware pyrogen free. We conclude that the products of normal saline in large packaging produced by local manufactures all meet the testing standards of pyrogen free status.