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目的 :考察替加氟注射液的细菌内毒素检查法的可行性并进行检查。方法 :采用中华人民共和国药典 2 0 0 0年版细菌内毒素检查法。结果 :替加氟注射液 4 0倍稀释液可用灵敏度 0 .2 5Eu·mL-1的鲎试剂作细菌内毒素检查。结论 :3个批号的替加氟注射液经检查均符合要求。
Objective: To investigate the feasibility and test of bacterial endotoxin test for tegafur injection. Methods: The People’s Republic of China Pharmacopoeia 2000 edition of bacterial endotoxin test. Results: Tegafur injection 40 times dilution can be used sensitivity 0. 25Eu · mL-1 鲎 reagent for bacterial endotoxin test. CONCLUSION: Tegafur injection of 3 batches all met the inspection requirements.