动态比浊法测定替硝唑葡萄糖注射液中细菌内毒素含量

Content of Bacterial Endotoxin in Tinidazole with Glucose Injection determined by Kinetic Turbidimetry

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 to determine the content of bacterial endotoxin in tinidazole with glucose injection(TGI). Method: Each of four groups TGI, which were produced by four different factories, was diluted into 0.5 mg·ml-1. The content of bacterial endotoxin determined by kinetic turbidimetry through obstructing test and verifying test. Result: The result obtained by kinetic turbidimetry was consistent with the result obtained by pyrogen test. The recovery were 102.6%, 101.7%, 98.7% and 97.6% , respectively. Conclusion: The TGI diluted into 0.5 mg·ml-1 may eliminate its obstruction to TAL reagent, and may be used in routine test.