摘要
目的修订米力农注射液细菌内毒素检查法质量标准。方法按《中国药典》2010年版二部,修改本品细菌内毒素限值,并研究米力农注射液对细菌内毒素检查试验的干扰情况。结果本品用1M NaOH调节pH值近中性后对细菌内毒素检查无干扰作用。结论修订了本品细菌内毒素检查法质量标准,修订后的标准适用于本品细菌内毒素检查。
Objective To revise the criterion for bacterial endotoxin test of Milrinone Injection. Methods The limit on the amount of bacterial endotoxin in this product was revised according to CP2010, and the interference of the product in bacterial endotoxin test was studied. Results Milrinone Injection did not interfere in the test when its PI-I reached almost 7 after adding 1M NaOH. Conclusion The criterion for bacterial endotoxin test of this product was revised. It has been showed that this product is suitable for bacterial endotoxin test.
出处
《中国药事》
CAS
2012年第5期456-458,共3页
Chinese Pharmaceutical Affairs
基金
山东省自然科学基金(编号Q2008C06)
关键词
米力农注射液
细菌内毒素检查
干扰试验
Milrinone Injection
bacterial endotoxin test
interference test
