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目的:确立用鲎试剂(TAL)法检测泛影葡胺注射液中的内毒素。方法:参照《美国药典》23版及《中国药典》1995年版二部收载的细菌内毒素检查方法的要求进行试验。结果:用标示值灵敏度为0.5EU·ml~(-1)的鲎试剂检查泛影葡胺注射中的细菌内毒素是有效的。结论:0.5EU·ml~(-1)鲎试剂可以用于泛影葡胺注射液中的内毒素检测。鲎试剂(TAL)法可替代泛影葡胺注射液热原检查项目中的家兔(RT)法。
OBJECTIVE: To establish a method for the detection of endotoxin in meglumine diatrizoate injection by TAL method. Methods: The test was conducted according to the requirements of the bacterial endotoxin test method contained in the 23rd edition of the United States Pharmacopeia and the 1995 edition of the Chinese Pharmacopoeia. Results: Examination of bacterial endotoxin in diatrizoate injection with a titration of 0.5 EU · ml -1 was effective. Conclusion: 0.5EU · ml ~ (-1) 鲎 reagent can be used for endotoxin detection in meglumine diatrizoate injection. Reagent (TAL) method can replace the rabbit (RT) method in the pyrogen test of diatrizoate meglumine injection.