地塞米松磷酸钠注射液的细菌内毒素检查法

目的:探讨地塞米松磷酸钠注射液对细菌内毒素检查实验的干扰情况,并建立其细菌内毒素检查的质量标准.方法:参照《中国药典》2005年版二部附录XI E细菌内毒素检查法,用两个厂家的鲎试剂对两个厂家的地塞米松磷酸钠注射液进行干扰试验.结果:地塞米松磷酸钠注射液对细菌内毒素检查有干扰作用,但通过细菌内毒素检查用水稀释可消除干扰.结论:该制剂可以用细菌内毒素检查法(凝胶法)代替兔热原检查法.

Bacterial endotoxin test in dexamethasone sodium phosphate injection

Objective:To study the interferential effect of dexamethasone sodium phosphate injection on bacterial endotoxin test and to establish bacterial endotoxin test method. Methods: According to China Pharmacopoeia 2005, inhibition and enhancement test was performed with Amebocyte Lysate manufactured by two different companies in dexamethasone sodium phosphate injection manufactured by two different companies. Results: The injection can interfere with the bacterial endotoxins test, but the inhibition effect can be eliminated by appropriate dilution with BET water. Conclusions: The results suggest that bacterial endotoxins test (gel-clot method) can be used as an alternative method for the rabbit pyrogen test for Dexamethasone Sodium Phosphate Injection.