Harrison S J, Tsuji K, Enzinger R M
Prog Clin Biol Res. 1979;29:353-65.
The Limulus amebocyte lysate (LAL) test has been investigated as an alternative method to the USP pyrogen test for the detection of endotoxin contamination in these antibiotic preparations: clindamycin phosphate, lincomycin hydrochloride, neomycin sulfate, and spectinomycin hydrochloride. The antibiotic preparations were tested at the maximum concentrations that would not inhibit gelation of LAL. The USP pyrogen test was also performed for comparison. The LAL and the USP pyrogen tests correlated extremely well when an acceptance criterion based on the minimum pyrogenic dose (MPD) of endotoxin per human dose of drug was used for the LAL test. Use of this MPD provides a practical and feasible acceptance creiterion for the LAL test and assures that the LAL sensitivity approximates or surpasses that of the USP pyrogen test.
已对鲎试剂（LAL）检测法进行了研究，将其作为美国药典热原检测法的替代方法，用于检测这些抗生素制剂中的内毒素污染：磷酸克林霉素、盐酸林可霉素、硫酸新霉素和盐酸大观霉素。抗生素制剂在不会抑制鲎试剂凝胶化的最大浓度下进行检测。同时进行美国药典热原检测以作比较。当基于每剂人用药物的内毒素最低致热剂量（MPD）的接受标准用于鲎试剂检测时，鲎试剂检测与美国药典热原检测的相关性非常好。使用该MPD为鲎试剂检测提供了一个切实可行的接受标准，并确保鲎试剂的灵敏度接近或超过美国药典热原检测的灵敏度。
