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目的通过考察中国药科大学附属第一医院核医学科提供的氟[18F]脱氧葡糖注射液对细菌内毒素检查法试验的干扰实验情况,并确定其细菌内毒素检查法的可行性,排除了干扰性。方法参照《中国药典》2005年版二部附录XIE细菌内毒素检查法进行试验。结果供试品氟[18F]脱氧葡糖注射液每1ml含细菌内毒素的量应小于15Eu,该浓度下对鲎试验不存在干扰作用。
OBJECTIVE To investigate the feasibility of the bacterial endotoxin test to determine the feasibility of the bacterial endotoxin test by investigating the interference experiments of the fluorine [18F] dextrose injection on the bacterial endotoxin test provided by the Nuclear Medicine Department of the First Affiliated Hospital of China Pharmaceutical University Interference. Methods According to “Chinese Pharmacopoeia” 2005 edition two appendix XIE bacterial endotoxin test method for testing. Results for the test fluoride [18F] dextrose injection per 1ml bacterial endotoxin content should be less than 15Eu, the concentration of the test does not interfere with the test effect.