布比卡因碱细菌内毒素检测方法的建立

Establishment of Bupivacaine Bacterial Endotoxin Detection Method

建立布比卡因碱细菌内毒素检测方法。方法:参照《中国药典》2015版四部1143细菌内毒素检查法进行实验,用不同厂家的鲎试剂对布比卡因碱进行干扰实验。结果:当布比卡因碱稀释浓度为2 mg/mL时可消除对鲎试剂与细菌内毒素凝集反应的干扰。结论:布比卡因碱可用细菌内毒素检查法进行安全质量检查。

To establish a method for the determination of bacterial endotoxin of bupivacaine.Methods:The experiment was performed with reference to the four parts of the 1143 bacterial endotoxin test method of the Chinese Pharmacopoeia 2015,and the interference test of bupivacaine base was carried out by using limulus reagents from different manufacturers.Results:When the concentration of bupivacaine base was 2 mg/mL,the interference on the agglutination reaction between limulus reagent and bacterial endotoxin could be eliminated.Conclusion:Bupivacaine can be tested for safety and quality by bacterial endotoxin test.