鱼金注射液细菌内毒素检查方法的研究

A study on testing for bacterial endotoxin in Yu-Jin injection

目的 对鱼金注射液进行细菌内毒素检查研究 ,建立检查鱼金注射液中细菌内毒素的试验方法。方法 采用《中国药典 2 0 0 0年版》附录细菌内毒素检查方法。结果 干扰试验结果表明 :用标示灵敏度为 0 5Eu·ml-1的鲎试剂 ,将鱼金注射液稀释至 6倍时 ,对细菌内毒素检查无干扰作用。结论 用细菌内毒素检查法检查鱼金注射液中细菌内毒素是可行的。可用细菌内毒素检查法 (凝胶法 )代替家兔热原检查法控制其热原。

Aim To construct the methods of bacterial endotoxins test for Yu Jin injection. Methods Bacterial endotoxins test according to the addenda of 2000 Edition China Pharmacopoeia(second part). Result The backdrop can be avoided through diluting the preparation in 6 times. Conclusion The result shows that testing for bacterial endotoxin can instead of testing for pyrogen in matrine and sodium chloride injection.