地佐辛注射液细菌内毒素检查法研究

Study of bacterial endotoxin test for dezocine injection

目的建立地佐辛注射液细菌内毒素检查方法。方法参照《中国药典》2010版(二)部附录细菌内毒素检查法及其原则进行实验。结果当地佐辛注射液稀释至100倍时可消除对鲎试剂与细菌内毒素凝聚反应的干扰。结论可以用细菌内毒素检查法对地佐辛注射液进行热原检查。

Objective To establish the bacterial endotoxin test in Dezocine Injection. Methods According to the CHP（2010 Edt.）, inhibition or enhancement test forbacterial endotoxin test was carried out of sodium bicarbonate injection. Results The interference could be eliminated when Dezocine injection was diluted by 100 times. Conclusion bacterial endotoxin inspection method can be used for testing the pyrogen of Dezocine injection.