Cooper J F, Weary M E, Jordan F T
Charles River Endosafe, Charleston, South Carolina, USA.
PDA J Pharm Sci Technol. 1997 Jan-Feb;51(1):2-6.
Limulus amebocyte lysate (LAL) is activated by bacterial endotoxins and certain glucans (beta-D-glucan, LAL-RM). The potential for conflicting inter-laboratory results for LAL tests exists because commercial LAL reagents are highly variable in response to LAL-reactive glucans. The nature of beta-D-glucan activation of LAL and means for rendering LAL non-responsive to glucan are reviewed to provide a background for resolving conflicting data. Kinetic LAL methods are particularly useful for screening materials potentially contaminated with glucan. The presence of beta-D-glucan in parenterals is uncommon and is likely limited to products exposed to microbial or cellulosic materials. A scheme is suggested for identifying LAL-reactive glucans and for LAL release-testing without glucan interference.
鲎试剂（LAL）可被细菌内毒素和某些葡聚糖（β-D-葡聚糖，LAL-RM）激活。由于市售鲎试剂对LAL反应性葡聚糖的反应高度可变，因此鲎试剂检测存在实验室间结果相互矛盾的可能性。本文综述了β-D-葡聚糖激活鲎试剂的性质以及使鲎试剂对葡聚糖无反应的方法，为解决相互矛盾的数据提供背景。动力学鲎试剂方法对于筛选可能被葡聚糖污染的材料特别有用。注射剂中β-D-葡聚糖的存在并不常见，可能仅限于接触微生物或纤维素材料的产品。本文提出了一种方案，用于鉴定LAL反应性葡聚糖以及在无葡聚糖干扰的情况下进行鲎试剂释放试验。
