Tsuji K, Steindler K A, Harrison S J
Appl Environ Microbiol. 1980 Sep;40(3):533-8. doi: 10.1128/aem.40.3.533-538.1980.
A Limulus amoebocyte lysate gel-clotting method for the determination of endotoxin in a small-volume parenteral product has been described. Sample dilution with 0.1 M potassium phosphate monobasic buffer (pH 8.0) effectively eliminated assay interference, whereas dilution with water did not. The threshold pyrogenic dose for Escherichia coli EC-2 and O127:B8 endotoxins was determined to be 1.0 ng of endotoxin per kg of body weight. Not more than 1.0 ng of endotoxin (the threshold pyrogenic dose) per the highest recommended human dose or the USP pyrogen test dose per kg of body weight, whichever dose is more stringent, is a logical limit for the quantity of bacterial endotoxin in small-volume parenteral products. Excellent correlation was attained when this criterion was used to compare the Limulus amoebocyte lysate assay with the USP pyrogen test.
已描述了一种用于测定小容量注射剂产品中内毒素的鲎试剂凝胶法。用0.1M磷酸二氢钾缓冲液（pH 8.0）稀释样品可有效消除测定干扰，而用水稀释则不能。已确定大肠杆菌EC-2和O127:B8内毒素的热原阈值剂量为每千克体重1.0 ng内毒素。按每千克体重最高推荐人用剂量或美国药典热原试验剂量中更严格的剂量计算，每千克体重不超过1.0 ng内毒素（热原阈值剂量），是小容量注射剂产品中细菌内毒素含量的合理限度。当使用该标准将鲎试剂法与美国药典热原试验进行比较时，获得了极好的相关性。
