硫酸镁注射液中细菌内毒素的检测

目的　建立硫酸镁注射液的细菌内毒素检查法。方法　按中国药典 2000年版二部附录规定进行鲎试剂复核、样品干扰试验和样品测定。结果　含量为 25%的样品经 2倍稀释后,可用标示灵敏度为 0. 25EU·mL-1的鲎试剂检测其细菌内毒素,实验结果与临床应用情况相符。结论　鲎法检测硫酸镁注射液中的细菌内毒素结果可靠,方法实用可行,可代替兔法检测其热原。

Detection of bacterial endotoxin in magnesium sulfate injection

OBJECTIVE To study the detection methods of bacterial endotoxin in magnesium sulfate injection.METHOD According to the rules of the Chinese Pharmacopoeia , sensitivity test for tachypleus amebocyte lysate (TAL),inhibition or enhancment test and sample test for magnesium sulfate injection were carried out.RESULTS There was no interference with the bacterial endotoxin test after the sample was diluted. CONCLUSION The TAL can be used for detection of bacterial endotoxin in magnesium sulfate injection and can replace the pyrogen test of magnesium sulfate injection.