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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 explore the feasibility of detecting bacterial endotoxin in docetaxel injection by interference screening method. Methods: interference screening method for the interference test and endotoxin limit test. Results: The selection of 0.112 5EU · ml-1 sensitivity reagent can eliminate the test for the endotoxin test interference, and interfere with the primary screening test method can be identified one step docetaxel injection endotoxin test without interference The effective dilution range and the required sensitivity range of 鲎 reagents. CONCLUSIONS: The use of interfering primary screening to examine bacterial endotoxin in docetaxel injection will not only greatly reduce the workload of routine endotoxin tests, but also be feasible.