摘要
目的 :通过试验探讨采用干扰初筛法检测多烯紫杉醇注射液中细菌内毒素方法的可行性。方法 :运用干扰初筛法对供试品进行干扰试验和内毒素限量检查。结果 :选用 0 .12 5EU·ml-1以上灵敏度的鲎试剂可以消除供试品对内毒素检查的干扰 ,并且干扰初筛试验法一步就可以确定出多烯紫杉醇注射液对内毒素检查无干扰的有效稀释范围以及所需的鲎试剂灵敏度范围。结论 :采用干扰初筛法检查多烯紫杉醇注射液中细菌内毒素不但可以大大减少通常内毒素检查中的工作量 ,而且切实可行。
Objective: To determine whether the preliminary screening test can be used for the docetaxol injection or not.Method: According to the Pharmacopoeia of China (2000), the disturbance experiment and limited amount test of bacterial endotoxins with tachypleus amebocyte lysate (TAL) were performed.Result: Use of 0.125 EU·ml -1 TAL and increase of the dilution times could eliminate the disturbance of docetaxol injection with TAL.Conclusion: The preliminary screening test can be used in BET of the docetaxol injection.
出处
《中国药师》
CAS
2003年第10期621-622,644,共3页
China Pharmacist
关键词
多烯紫杉醇注射液
初筛法
干扰试验
细菌内毒素检查
鲎试剂
Docetaxol injection
Preliminary screening test
Disturbance experiment
Bacterial endotoxins test
TAL
