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目的 :研究用鲎试验取代家兔法检测右旋糖酐 40葡萄糖注射液中的细菌内毒素方法的可行性。方法 :分别用动态浊度法和凝胶法考察右旋糖酐 40葡萄糖注射液对鲎试验的干扰作用。结果 :动态浊度法干扰试验结果表明 ,右旋糖酐 40葡萄糖注射液原液对鲎试验约有 1倍的增强作用 ,样品 1∶1稀释后干扰消除 ;凝胶法干扰试验表明 ,右旋糖酐 40葡萄糖注射液原液 (0 .5 % )对鲎试验无干扰作用。结论 :可用鲎试验法检测右旋糖酐 40葡萄糖注射液中的细菌内毒素 ,建议其内毒素检查的限值为 0 .5EU/ml。用动态浊度法时样品至少作 1∶1稀释。
Objective: To study the feasibility of replacing the bacterial endotoxin in dextran 40 glucose injection with rabbit test by rabbit test. Methods: The interference effects of dextran 40 glucose injection on 鲎 test were investigated by dynamic turbidimetric method and gel method respectively. Results: The results of dynamic turbidity interference test showed that the dextran 40 glucose injection solution had about 1-fold enhancement effect on 鲎 test, the sample was diluted by 1: 1 dilution and the interference was eliminated. The interference test by gel method showed that dextran 40 glucose injection solution (0.5%) did not interfere with 鲎 test. CONCLUSION: Bacterial endotoxins in dextran 40 glucose injection can be detected by limulus test. The limit of endotoxin test is recommended to be 0.5 EU / ml. Samples should be diluted at least 1: 1 with dynamic turbidimetry.