摘要
目的验证注射用环磷腺苷细菌内毒素检查法的可行性。方法参照《中国药典》2005年版二部附录ⅪE试验方法,通过干扰/确证实验来确定注射用环磷腺苷的有效稀释浓度和细菌内毒素检查限值。结果注射用环磷腺苷的40倍稀释溶液无干扰作用,其细菌内毒素限值符合规定。结论注射用环磷腺苷可以通过细菌内毒素检查法来控制其细菌内毒素含量。
Aim To establish bacterial endotoxin test method of adenosine cyclophosphate for injection. Method The test was carried out according to the guideline of interfering test and producure specified in Chinese Pharmacopeia 2005. Result The injection did not interfere with limulus agent in 40 diluted concentration. Conclusion Bacterial endotoxin test can be used for adenosine cyclophosphate for injection.
出处
《安徽医药》
CAS
2006年第8期567-568,共2页
Anhui Medical and Pharmaceutical Journal
关键词
注射用环磷腺苷
细菌内毒素
鲎试剂
adenosine cyclophosphate for injection
bacterial endotoxin
limulus agent
