注射用盐酸丙帕他莫的细菌内毒素检查  

Bacterial Endotoxin Test of Propacetamol Hydrochloride for Injection

作　　者：程春雷 高天勤[2] 曹珍艳 

机构地区：[1]山东省药品检验所,山东济南250101 [2]山东滨州医学院附属医院,山东滨州256603

出　　处：《中国医药工业杂志》2011年第3期219-221,共3页Chinese Journal of Pharmaceuticals

摘　　要：盐酸丙帕他莫（propacetamol hydrochloride,1）为非成瘾性解热镇痛药[1],原料药已载入欧洲药典6.0版。在国家药品标准YBH09512008中,采用家兔法控制其热原质。由于1具有解热作用,Pyrogens in propacetamol hydrochloride（1） for injection were examined by pyrogen test and bacterial endotoxin test.Nine rabbits were divided into 3 groups and were iv injected 1（10 mg/kg）,endotoxin（2,5 EU/kg） and 1（10 mg/kg）＋ 2（5 EU/kg）,respectively.The body temperature of rabbits in the endotoxin group increased obviously,while the results of the other two groups showed the products met the requirements for the absence of pyrogens.Meanwhile,the endotoxin experiment of 1 was carried out and it was showed that 1 for injection had no interference in the bacterial endotoxin test after sample was diluted for 120 times.Because 1 belongs to one of antipyretic-analgesic drugs,it is the bacterial endotoxin test method but not pyrogen test that should be used for its quality control.

关 键 词：细菌内毒素检查 盐酸 注射用 解热镇痛药 药品标准 解热作用 原料药 热原质 

分 类 号：R927.12[医药卫生—药学]