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藥物食品檢驗局調查研究年報

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篇名 大型輸注液內毒素污染之測定
卷期 6
並列篇名 Endotoxin Contamination of Large Volume Parenterals as Determined by LAL Method
作者 謝榮添魏秀義林嘉伯
頁次 064-066
關鍵字 大型輸注液LAL Test內毒素TSCI
出刊日期 198809

中文摘要

本研究為探討大型輸注液內毒素污染的情形,於七十五年間在台灣地區普遍抽購大型輸注液549件,以LAL試驗法進行其細菌內毒素檢測,呈陽性者有9件,佔1.64%。其中國產製劑517件,呈陽性者有8件,佔1.55%;輸入製劑32件呈陽性者有1件,佔3.1%。此9件LAL試驗呈陽性者經家兎熱原試驗檢驗結果均為陰性。

英文摘要

From July 1985 to June 1986, We examined 549 samples of large volume parenterals by the limulus amebocyte lysate (LAL) method. Of the total samples tested, 9 (1.64%) were found contaminating endotoxin. However, by using the offical method for pyrogen test, none of the 9 endotoxin postive samples was able to induce typical fever response in rabbits.

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