显色基质法定量检测盐酸多沙普仑注射液的细菌内毒素

Quantitative Determination of Bacterial Endotoxin in Doxapram Hydrochloride Injection by Chromogenic Substrate Method

目的：建立定量检测盐酸多沙普仑注射液中细菌内毒素的方法。方法：采用显色基质法,按照《中国药典》相关方法对不同批号的盐酸多沙普仑注射液分别进行干扰试验,确立其不干扰质量浓度。结果：盐酸多沙普仑注射液稀释至5 mg/ml时无干扰作用,回收率为50%～100%。结论：显色基质法可用于盐酸多沙普仑注射液中细菌内毒素含量的定量检测。

OBJECTIVE：To set up a method for quantitative determination of bacterial endotoxin in Doxapram hydrochloride injection. METHODS：The interference test of different batches of Doxapram hydrochloride injection was conducted according to Chinese Pharmacopeia,so as to determine the noninterference concentration by chromogenic substrate method. RESULTS：The interference between the sample and the relative chromogenic substrate was eliminable when the sample was diluted to 5 mg/ml. Recovery rates were 50%-100%. CONCLUSIONS：The chromogenic substrate method is suitable for quantitative detection of bacterial endotoxin content in Doxapram hydrochloride injection.