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目的:建立氧氟沙星葡萄糖注射液的细菌内毒素检查法。方法:用缓血酸胺(三羟甲基氨基甲烷)缓冲溶液代替细菌内毒素检查用水做供试品稀释,按《中国药典》2000版二部收载的细菌内毒素检查法进行实验。结果:缓血酸胺缓冲溶液能排除氧氟沙星葡萄糖注射液对鲎试剂凝胶反应的干扰。结论:样品稀释剂改进后,可用细菌内毒素检查法代替兔法做氧氟沙星葡萄糖注射液热原检查。
Objective: To establish a bacterial endotoxin test for ofloxacin and glucose injection. Methods: Tricine buffer solution was used to replace bacterial endotoxin test water for test dilution, according to the “Chinese Pharmacopoeia” 2000 edition of the bacterial endotoxin test method carried out in two experiments. Results: Tacrolimus buffer solution could eliminate the interference of ofloxacin and glucose injection on the gel reaction of Tachyzoites. Conclusion: After the sample diluent is improved, the bacterial endotoxin test can be used instead of the rabbit test to detect the pyrogen of the ofloxacin glucose injection.