调节不同pH值的免疫吸附洗脱液的细菌内毒素测定  

Bacterial endotoxin test with immune adsorption eluent by adjusting pH value

作　　者：岩林苹[1] 曹燕丽[1] 吴晶晶[1] 王婷[1] 苏华[1] 任海祥[1] 

机构地区：[1]南京军区南京总医院制剂科,江苏南京210002

出　　处：《安徽医药》2014年第5期833-836,共4页Anhui Medical and Pharmaceutical Journal

摘　　要：目的选择不同浓度的氢氧化钠碱性调节剂或直接稀释法对免疫吸附洗脱液的pH值进行调节比较,建立免疫吸附洗脱液的细菌内毒素检查方法。方法根据《中国药典》2010年版第二部附录收载的细菌内毒素检查方法,采用鲎试剂法对免疫吸附洗脱液进行干扰试验。结果稀释32倍的免疫吸附洗脱液对细菌内毒素与鲎试剂的反应无干扰,选择灵敏度为0.015EU·mL-1的鲎试剂进行细菌内毒素检查。结论选择直接稀释法调节供试品的pH值更优于低浓度氢氧化钠碱性调节剂调节供试品的pH值对其进行细菌内毒素的检查。Objective To establish a method for testing bacterial endotoxin with immune adsorption eluent by adjusting pH value with sodium hydroxide at different concentration as an alkalinity regulator or by direct dilution method. Methods The interference experiments with tachypleus amebocyte lysate（ TAL） method on the immune adsorption eluents were performed according to the bacterial endotoxin test in Chinese Pharmacopoeia 2010（ Section 2）. Results The immune adsorption eluent did not interfere with the bacterial endotoxins test when it was diluted 32 times. Tachypleus amebocyte lysate was used with the sensitivity of 0. 015 EU·mL-1. Conclusions It is better to adjust pH value by direct dilution method for testing bacterial endotoxin of immune adsorption eluent than with sodium hydroxide as an alkalinity regulator.

关 键 词：免疫吸附洗脱液 细菌内毒素 PH值 氢氧化钠碱性调节剂 

分 类 号：R446.6[医药卫生—诊断学]