盐酸尼卡地平葡萄糖注射液细菌内毒素检查  

Bacterial Endotoxin Test for Nicardipine Hydrochloride Glucose Injection

作　　者：郑霞[1] 赵毓梅[1] 刘春[1] 

机构地区：[1]海南省药品检验所,海口市570102

出　　处：《中国药房》2008年第1期56-57,共2页China Pharmacy

摘　　要：目的:建立盐酸尼卡地平葡萄糖注射液的细菌内毒素检查方法。方法:根据2005年版《中国药典》(二部)附录细菌内毒素检查法进行试验。结果:当水为溶剂时,样品对细菌内毒素检查法有干扰作用;改用稀释剂Ⅰ作为溶剂,干扰预试验和干扰试验结果表明,样品在4倍以上稀释浓度时可排除干扰。结论:盐酸尼卡地平葡萄糖注射液按限值L=0.5EU.mL-1进行细菌内毒素检查是可行的,可以用细菌内毒素检查法取代热原检查法检测盐酸尼卡地平葡萄糖注射液。OBJECTIVE： To establish a method for the bacterial endotoxin test of nicardipine hydrochloride glucose injection. METHODS： The bacterial endotoxin test was carried out according to the bacterial endotoxin test in the addenda of China Pharmacopeia 2005 edition （second part）. RESULTS： Nicardipine hydrochloride glucose injection showed interference on the bacterial endotoxin test when water was taken as solvent. The preliminary interference test and interference test revealed that using thinner I as solvent, the sample injection in over 4- fold dilution had no interference on the bacterial endotoxin test. CONCLUSIONS： It is feasible for bacterial endotoxin test of nicardipine hydrochloride glucose injection be conducted in a limit value of 0.5 EU · mL^-1. The bacterial endotoxin text can substitute pyrogen test in the detection of nicardipine hydrochloride glucose injection.

关 键 词：盐酸尼卡地平葡萄糖注射液 细菌内毒素检查 稀释剂Ⅰ 干扰试验 

分 类 号：R927.11[医药卫生—药学]