Takahashi S, Yano S, Nagaoka Y, Kawamura K, Minami S
J Pharm Sci. 1983 Jul;72(7):739-42. doi: 10.1002/jps.2600720706.
The rabbit pyrogen test (specified in the pharmacopeia) and the Limulus amebocyte lysate (LAL) test are influenced by high concentrations of certain antibiotics. Therefore, it has not been possible to detect trace amounts of endotoxin which may contaminate these antibiotics. To detect trace amounts of endotoxin in injectable sodium ampicillin, an ultrafiltration technique was utilized which removed the antibiotic and left a solution which contained predominantly the endotoxin. After ultrafiltration, a trace amount of pyrogen (which otherwise could not be detected) was found using both the rabbit pyrogen and the LAL tests. The endotoxin was also determined quantitatively using a chromogenic endotoxin reagent which is made by combining the Limulus amebocyte lysate and a synthetic substrate with a suitable chromophore.
兔热原试验（药典规定）和鲎试剂试验受某些抗生素高浓度的影响。因此，无法检测出可能污染这些抗生素的痕量内毒素。为检测注射用氨苄西林钠中的痕量内毒素，采用了超滤技术，该技术可去除抗生素，留下主要含有内毒素的溶液。超滤后，通过兔热原试验和鲎试剂试验均发现了痕量热原（否则无法检测到）。还使用一种显色内毒素试剂对内毒素进行了定量测定，该试剂是通过将鲎试剂与一种带有合适发色团的合成底物结合制成的。
