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目的:确定合理的注射用草酸铂的内毒素限值,建立其快速准确的细菌内毒素检查法。方法:参照《中国药典》2000 版二部细菌内毒素检查法进行试验。结果:注射用草酸铂细菌内毒素限值为L=1.0 EU·mg-1。当用灵敏度为0.25 EU·ml-1 的鲎试剂进行细菌内毒素检查时,注射用草酸铂溶液浓度为0.3 mg·ml-1。结论:注射用草酸铂可用鲎试剂进行细菌内毒素检查。
OBJECTIVE: To determine the reasonable limits of endotoxin of oxaliplatin for injection and to establish its rapid and accurate bacterial endotoxin test. Methods: According to the Chinese Pharmacopoeia 2000 edition two bacterial endotoxin test method. Results: The limit of bacterial endotoxin for injection with oxalic acid was L = 1.0 EU · mg-1. Bacterial endotoxins were tested for bacterial endotoxins with a titration reagent of 0.25 EU · ml-1 at a concentration of 0.3 mg · ml-1. CONCLUSION: Bacterial endotoxins can be tested with limulus oxalic acid for injection.