茵栀黄注射液中细菌内毒素的检测

Detection of bacterial endotoxin in Inzhihuang injection

目的:研究细菌内毒素检察法应用于茵栀黄注射液的可行性,为临床安全用药和基层快速检验提供依据。方法:按照中国药典2000年版二部附录ⅪE复核鲎试剂灵敏度并进行样品干扰试验和样品细菌内毒素测定。结果:样品稀释18倍可排除干扰,稀释20倍为最佳测定浓度。结论:用鲎试剂检测茵栀黄注射液中的细菌内毒素灵敏、快速,结果可靠,可代替兔法检查其热原。

Objective: To study the detection methods of bacterial endotoxin in Inzhihuang injection. Methods: According to the rules of the Chines pharmacopoeia, sensitivity test for tachypleus amebocyte lysate (TAL), inhibition or enhancement test and sample test for Inzhihuang injection were carried out. Results: The gelling of TAL was inhibited when the concentration of Inzhihuang injection was 18 times or more diluted. The maximum noninterference concentration was 18 times dilution and the best testing concentration was 20 times dilution. Conclusion: The TAL can be used for detection of bacterial endotoxin in Inzhihuang injection. This method was sensitive and rapid and can replace the pyrogen test of Inzhihuang injection.