精制橄榄油细菌内毒素检查的可行性研究

Study on the Test Method of Bacterial Endotoxin in Refined Olive Oil

目的对精制橄榄油进行凝胶法干扰试验,建立精制橄榄油细菌内毒素的检查方法。方法按2010年版《中国药典》(二部)"细菌内毒素检查法",用不同厂家的鲎试剂对不同批号的精制橄榄油分别进行干扰试验。结果精制橄榄油稀释至浓度83.4mg/mL或以下稀释浓度的溶液对细菌内毒素检查法无干扰作用。结论精制橄榄油注射液进行细菌内毒素检查是可行的。

Objective To establish a bacterial endotoxin test for refined olive oil injection.Methods According to the bacterial endotoxins test in Chinese Pharmacopoeia 2005.Different batches of refined olive oil injection from different TAL manufacturers were underwent the interference tests.Results There was no interference in the bacterial endotoxins test when the concentration of refined olive oil is less than or equal to the detection limit 83.4mg/mL.Conclusion Carrying out the bacterial endotoxin test for refined olive oil injection is feasible.