替加氟注射液的细菌内毒素检查

The bacterial endotoxins test of tegafur injection

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 inspect on the feasibility of bacterial endotoxins test (BET) for tegafur injection and to test.Methods:BET of China Pharmacopoeia version 2000.Results:40 times dilution of tegafur injection could be tested by tachypleus amebocyte lysate(TAL) with the sentivity of 0.25 Eu·mL -1 .Conclusion:Three batches of tegafur injection met the requirements by test.