异烟肼注射液细菌内毒素检查法建立及方法学研究

Study on bacterial endotoxin test establishment and methodology of isoniazid injection

目的建立异烟肼注射液细菌内毒素检查法。方法参照中国药典2005年版二部附录XIE细菌内毒素检查法进行实验。结果当异烟肼注射液配制至1.67mg.mL-1浓度时,进行细菌内毒素检查无干扰作用。结论异烟肼注射液采用细菌内毒素检查方法可行。

OBJECTIVE To establish a method for testing bacterial endotoxin of isoniazid injection. METHODS According to the bacterial endotoxin test approved by the appendix XI E of Chinese Pharmacopoeia 2005 edition vol Ⅱ. RESULTS Isoniazid injection did not interfere with bacterial endotoxin test when it was diluted to the concentration of 1.67 mg·mL^- 1. CONCLUSIONS It is suitable for bacterial endotoxin test of isoniazid injection.