枸橼酸钠注射液细菌内毒素检查方法的考察  

Studies of Bacterial Endotoxins Test of Sodium Citrate Injection

作　　者：何进[1] 史国兵[1] 高军[1] 陈金旺[2] 

机构地区：[1]沈阳军区总医院药剂科,辽宁沈阳110840 [2]大连医科大学临床药学系,辽宁大连116027

出　　处：《解放军药学学报》2011年第3期254-255,共2页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立枸橼酸钠注射液细菌内毒素检查方法。方法按《中国药典》2005年版附录细菌内毒素检查法,分别进行了鲎试剂灵敏度复核试验、细菌内毒素干扰试验。结果枸橼酸钠注射液稀释6倍后,不干扰鲎试剂与细菌内毒素的凝胶反应。结论可用细菌内毒素检查法替代家兔法检查枸橼酸钠注射液中的细菌内毒素。Objective To establish a method of bacterial endotoxin test of sodium citrate injection by gel clot.Methods The method was based on the bacterial endotoxin test in the appendix of Chp 2005.A series of tests were performed,such as the sensitivity test of tachypleus amebocyte lysate,first interference test and interference tests.Results No interference was found after the sodium citrate injection was diluted 6 times in the bacterial endotoxin interference factors test.Conclusion The present method can replace the pyrogen test with rabbits for examination of bacterial endotoxin of sodium citrate injection.

关 键 词：枸橼酸钠注射液 细菌内毒素检查 干扰试验 

分 类 号：R927.12[医药卫生—药学]