大型輸注液內毒素污染之測定

Endotoxin Contamination of Large Volume Parenterals as Determined by LAL Method

謝榮添(Jung-Tian Hsieh) ； 魏秀義(Shiow-Yih Wey) ； 林嘉伯(Chia-Po Lin)

《藥物食品檢驗局調查研究年報》 6號 (1988/09) Pp. 64-66

https://doi.org/10.6946/ASRNL.198809.0064

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。

關鍵字

大型輸注液 ； LAL Test ； 內毒素

並列摘要

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.