调节不同 pH 值的免疫吸附洗脱液的细菌内毒素测定

摘要

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 experi-ments with tachypleus amebocyte lysate ( TAL) method on the immune adsorption eluents were performed according to the bacterial en -dotoxin 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 .Conclu-sions It is better to adjust pH value by direct dilution method for testing bacterial endotoxin of immune adsorption eluent than with so -dium hydroxide as an alkalinity regulator .%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0．015 EU· 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。