盐酸利多卡因注射液细菌内毒素检查法的建立

Bacterial Endotoxin Test for Lidocaine Hydrochloride Injection

为建立盐酸利多卡因注射液细菌内毒素检查法,笔者参照《中国药典》2005年版细菌内毒素检查法进行试验,结果该药在稀释4倍(5mg.mL-1)后对细菌内毒素无干扰作用。该药可采用细菌内毒素检查法控制药品质量。

A Endotoxin test method for Lidocaine Hydrochloride Injection was established. Experiment was conducted according to the Bacterial of Endotoxin test in Volume Ⅱ, Edition 2005, Chinese Pharmacopeia. At the concentration of 4mg · mL^-1 , Lidocaine Hydrochloride has no interferential effects on the galation reaction of Endotoxln and Tachypleus Amebocyte Lysate. Endotoxin test method can be adopted on the quality control of Lidocaine Hydrochloride Injection.