【摘要】 目的 :对生脉注射液进行细菌内毒素试验考察。方法 :选择一定灵敏度的鲎试剂 ,在最大有效稀释范围内 ,考察在不同稀释度下该制剂的干扰作用。结果 :选用灵敏度为 0 .5EU/mL的鲎试剂 ,1∶8的稀释度下 ,该制剂具有明显的增强作用 ;可改用灵敏度为 0 .2 5EU/mL的鲎试剂 ,将样品稀释成 1∶16的浓度 ,则增强作用可以消除。结论 :在 1∶16的稀释度下 ,可用灵敏度为 0 .2 5EU/mL的鲎试剂进行细菌内毒素检查 ,从而控制细菌内毒素的限量。更多还原

【Abstract】 Objective: To perform the bacterial endotoxin test of Pulse-Engendering Injection.Methods: The interference actions of the different dilutabilities of injection at the greatest effective diluent range were observed with some sensitivity of TAL. Results: When 0.5EU/ml sensitivity of TAL was used and the dilutability of sample was 1∶8, the injection showed obvious enhancement action, but when 0.25EU/ml senitiity of TAL was used and the dilutability was 1∶16, the enhancement action of injection could be eliminated. Conclusion: The bacterial endoxin test can be carried out with 0.25EU/ml sensitivity of TAL when the dilutability of sample is 1∶16, the limit dose of bacterial endotoxin is controlled thereby.更多还原