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頁籤選單縮合
題 名 | 市售大型輸注液生理食鹽水之熱原調查=Pyrogen Testing of Large Commercial Packages of Normal Saline |
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作 者 | 許慧娟; 魏秀義; 江建勳; 林嘉伯; | 書刊名 | 藥物食品檢驗局調查研究年報 |
卷 期 | 17 1999.10[民88.10] |
頁 次 | 頁63-66 |
分類號 | 412.36 |
關鍵詞 | 生理食鹽水; 熱原試驗; 兔子; Normal saline; Pyrogen test; Rabbit; |
語 文 | 中文(Chinese) |
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 家國內製造廠所製造,檢體包 裝則有 4 種,包括 500mL 的玻璃瓶、塑膠瓶、軟袋裝及 1000mL 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 ℃ ),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. |
本系統中英文摘要資訊取自各篇刊載內容。