氧氟沙星注射液细菌内毒素定量检查法研究

Determination of the Content of Bacterial Endotoxin in Ofloxacin Injection by Kinetic Turbidimetric Assay

目的 :建立用细菌内毒素定量检查法测定氧氟沙星注射液中细菌内毒素含量的方法。方法 :采用动态比浊法 ,通过干扰实验和验证实验 ,测定 4批不同厂家生产的氧氟沙星注射液中细菌内毒素含量。结果 :4批氧氟沙星注射液中细菌内毒素含量测定的回收率分别为 10 4.1% ,10 8.2 % ,95 .4%和 98.7% ;细菌内毒素含量测定结果与热原检查结果一致。结论 :氧氟沙星注射液稀释 4倍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 Ofloxacin injection. Methods: Four batches of Ofloxacin injections produced by four different factories were used for the determination of the content of bacterial endotoxin by kinetic turbidimetric technique, through obstructing test and verifying test. Results: The result determined by kinetic turbidimetric assay is consistent with the result determined by pyrogen test and the recovery is 104.1%, 108.2%, 95.4% and 98.7%, respectively. Conclusion: Ofloxacin injection diluted by 4 times may overcome its obstruciton to the TAL (tachyp EUS Amebocte Iysate) reagent and the method may be used in routine test.