盐酸普鲁卡因注射液细菌内毒素检查的实验研究

The Study on Bacterial Endotoxin Test for Procaine Hydrochloride Injection

目的建立盐酸普鲁卡因注射液的细菌内毒素检查方法。方法根据中国药典2000版细菌内毒素检查法应用和细菌内毒素检查法指导原则要求进行实验。结果样品经适当的稀释,选用0.125EU·mL-1的鲎试剂无干扰作用。结论细菌内毒素检查法可用于盐酸普鲁卡因注射液的质量控制。

OBJECTIVE To establish a method of bacterial endotoxin test for procaine hydrochloride injection.METHODS The test was conducted according to bacterial endotoxin test method and the application guideline requested for bacterial endotoxin test method included in the China Pharnacopeia,2000.RESULTS There was no interfering after the sample was diluted with limulus amebocyte lysate of which the sensitivity was 0.125EU·mL -1.CONCLUSION It is proved the bacterial endotoxin test can be used for defeeting the endotoxin in procaine hydrochloride injection.