摘要
目的:建立注射用丹参多酚酸盐的细菌内毒素检查方法。方法:按《中国药典》2010年版(二部)附录ⅪE细菌内毒素检查法进行操作。结果:注射用丹参多酚酸盐稀释至0.8 mg·ml^(-1)及以下浓度对鲎试剂干扰试验无干扰作用。结论:注射用丹参多酚酸盐可采用细菌内毒素检查法(凝胶法)进行细菌内毒素的限量检查。
Objective：To establish a method for the bacterial endotoxin test of salvianolate for injection.Method：The bacterial endotoxin test was carried out according to the requirements in the appendix XI E of Chinese Pharmacopeia（edition 2010,VolⅡ）.Result： The salvianolate for injection at the concentration not greater than 0.8 mg ？ ml ~ showed no interference on tachypiens amebocyte lysate teat.Conclusion：Bacterial endotoxin test（gel process） is applicable in the bacterial endotoxin limit test of salvianolate for injection.
出处
《中国药师》
CAS
2012年第5期685-687,共3页
China Pharmacist
