替硝唑注射液细菌内毒素检查方法的研究

The bacterial endotoxin test for tinidazole injection

目的建立替硝唑注射液的细菌内毒素检查法。方法按中国药典2000年版附录细菌内毒素检查法要求进行实验。结果替硝唑注射液1→2稀释后,不干扰鲎试剂与细菌内毒素的凝胶反应。结论可用细菌内毒素检查法替代热原检查法对替硝唑注射液进行热原检查。

Objective To establish a bacterial endotoxin testing method for tinidazole injection.Method Thetests were conducted according to appendix IX E of Chp 2000. Results Ornidazole and sodium chloride injec-tion was diluted to 1 → 2.The regression equation showed that the sample solution had no interforence toLAL,could be used with less interference.Conclusion Bacterial endotoxin test for tinidazole injection canreplace the pyrogen test.