摘要
目的 通过实验以考察注射用卡铂细菌内毒素检查方法的可行性。方法 按照中国药典 2 0 0 0年版二部附录收载的细菌内毒素检查方法进行试验 ,并与热原家兔检查法进行比较。结果 注射用卡铂在 1.0mg·mL-1浓度内对细菌内毒素与鲎试剂的反应无干扰作用 ,细菌内毒素限值为 0 .5EU/mg。 结论 注射用卡铂的热原检查可以用细菌内毒素检查法替代家兔法。
OBJECTIVE To establish the bacterial endotoxin testing method (BET) for carboplatin for injection. METHOD The test was conducted according to the method included in the Chinese Pharmacopoeia 2000. Rabbit method for pyrogens was also done compared with BET method. RESULTS The carboplatin for injection neither inhibited nor enhanced the test when the concentration was below 1.0 mg·mL -1. Testing limit of bacterial endotoxin was 5.0EU·mg -1. CONCLUSION Bacterial endotoxin in carboplatin for injection can be determined with BET method instead of PM method.
出处
《现代应用药学》
CSCD
北大核心
2004年第3期215-217,共3页
