摘要
目的建立乳糖酸阿奇霉素注射液细菌内毒素检查方法。方法按《中国药典》2010年版二部附录细菌内毒素检查法,对不同批号的样品进行了干扰试验和细菌内毒素检查。结果高浓度乳糖酸阿奇霉素注射液溶液对TAL与细菌内毒素的凝集反应有干扰作用,经稀释后可排除干扰。结论本品可采用细菌内毒素检查法代替热原检查法进行质量控制。
OBJECTIVE To establish a method for bacterial endotoxin test of Azithromycin Lactobionate Injection. METHODS According to ChP. 2010 edition Vol Ⅱ Appendix XIE ,the interference test and bacterial endotoxin test of different batches of samples were carried out. RESULTS There was interference in the agglutinate reaction between the sample and the relative TAL with the high concentration of Azithromycin Lactobionate Injection, and the interference was eliminated after diluted. CONCLUSION The bacterial endotoxin test can be used for the quality control of Azithromycin Lactobionate Injection instead of Pyrogen test.
出处
《海峡药学》
2014年第7期69-71,共3页
Strait Pharmaceutical Journal
关键词
乳糖酸阿奇霉素注射液
细菌内毒素检查
干扰试验
Azithromycin Lactobionate Injection
Bacterial endotoxin test
Interference test
