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目的:建立替硝唑葡萄糖注射液中细菌内毒素含量测定方法。方法:将4批不同厂家生产的替硝唑葡萄糖注射液稀释到0.5mg·ml~(-1),采用动态比浊法,通过干扰实验和验证实验,测定替硝唑葡萄糖注射液中细菌内毒素含量。结果:细菌内毒素含量测定的回收率分别为102.6％,101.7％,98.7％和97.6％;细菌内毒素含量测定结果与热原检查结果一致。结论:替硝唑葡萄糖注射液稀释到0.5mg·ml~(1)即可消除其对鲎试剂的干扰,可用于常规检验。
Objective: To establish a method for the determination of bacterial endotoxin in tinidazole glucose injection. Methods: Tinidazole glucose injection was diluted to 0.5 mg · ml ~ (-1) in 4 batches of different manufacturers. The turbid method was used to determine the content of tinidazole glucose in tinidazole glucose injection by interference experiments and validation experiments Toxin content. Results: The recoveries of bacterial endotoxin were 102.6%, 101.7%, 98.7% and 97.6%, respectively. The results of bacterial endotoxin were consistent with those of pyrogen test. Conclusion: The tinidazole dextrose injection diluted to 0.5mg · ml ~ (1) to eliminate the interference of limulus reagent, can be used for routine testing.