Murata H, Kobayashi M, Iio M, Yamada H, Chilba K
J Nucl Med. 1976 Dec;17(12):1088-92.
The basic sensitivity of the Limulus test and the inhibitory factors were examined in 21 radiopharmaceuticals commonly used in Japan. The sensitivity of the Limulus test using pre-gel was found to be 1 mug/ml for Escherichia coli endotoxin. This sensitivity is about ten times that of the rabbit test adopted by USP and JP. The Limulus test was applicable, with full sensitivity and without inhibitory reaction, for the evaluation of 99mTcO4-, 99mTc-albumin, 99mTc-MAA, 99,Tc-Sn-colloid, 131I-Hippuran, Na131I, Na251CrO49, 67Ga citrate, and 57Co-bleomycin as commercially supplied. On the other hand, with 111In-DTPA, 99mTc-phytate, 99mTc-pyrophosphate, 99mTc-DTPA, 131I-polyvinylpyrrolidone (PVP), 59FeCl3, Na232PO4, 198Au colloid, and selenomethionine (Se-75), the pH required adjustment to avoid inhibition of the gelation reaction. Benzyl alcohol showed an inhibitory effect on the gelation reaction at concentrations of more than 1%. Iodine-131-Bromsulphalein (BSP) and 131I-rose bengal showed intense inhibition of the gelation reaction.
对日本常用的21种放射性药物进行了鲎试剂检测的基本灵敏度和抑制因子检测。发现使用预凝胶的鲎试剂检测对大肠杆菌内毒素的灵敏度为1微克/毫升。该灵敏度约为美国药典和日本药典采用的家兔检测法的10倍。鲎试剂检测适用于对市售的99mTcO4-、99mTc-白蛋白、99mTc-MAA、99mTc-Sn-胶体、131I-马尿酸、Na131I、Na251CrO49、67Ga柠檬酸盐和57Co-博来霉素进行评估,具有完全灵敏度且无抑制反应。另一方面,对于111In-DTPA、99mTc-植酸盐、99mTc-焦磷酸盐、99mTc-DTPA、131I-聚乙烯吡咯烷酮(PVP)、59FeCl3、Na232PO4、198Au胶体和硒代蛋氨酸(Se-75),需要调整pH以避免抑制凝胶化反应。苯甲醇在浓度超过1%时对凝胶化反应有抑制作用。131I-溴磺酞钠(BSP)和131I-玫瑰红对凝胶化反应有强烈抑制作用。