摘要
目的 :研究抑制静脉注射人免疫球蛋白 (IVIG)细菌内毒素检查的因素。方法 :设计系列试验 ,复核鲎试剂灵敏度并验证其内毒素限度 ,观察赋形剂及 pH对IVIG内毒素检查结果的影响 ,找出IVIG内毒素检查法的关键抑制因素。结果 :低 pH条件对IVIG的细菌内毒素检查有抑制作用。结论 :改变低 pH条件 ,细菌内毒素检查法可代替家兔法用于IVIG的热原检查。
OBJECTIVE:To study the restraining factors in the intravenous immune globulin(IVIG.)bacterial endotoxin test.METHODS:A series tests were designed;the sensitivity of limulus was checked and the limit of endotoxin was validated;the effects of vehicle and pH value on the IVIG endotoxin test results were observed so as to find out the chief restraining factors of this test method.RESULTS:Lower pH value has an inhibition effect on the in IVIG bacterial endotoxin test.CONCLUSION:Bacterial endotoxin test can replace the rabbit testing method in the pyrogen test of IVIG.When the condition of lower pH is changed.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第5期379-381,共3页
China Pharmacy
关键词
静脉注射人免疫球蛋白
细菌内毒素检查
抑制因素
Intravenous immune globulin(IVIG)
Bacterial endotoxin test(BET)
Restraining factor
