摘要
目的探讨采用干扰初筛法检测注射用头孢哌酮钠舒巴坦(1∶1)中细菌内毒素的可行性。方法运用干扰初筛法对供试品进行干扰试验和细菌内毒素限量检查。结果选用0.25EU/mL以上灵敏度的鲎试剂可以消除供试品对细菌内毒素检查的干扰,并且干扰初筛试验法一步就可以确定出供试品对细菌内毒素检查无干扰的有效稀释范围,以及所需的鲎试剂灵敏度范围。结论采用干扰初筛法检查注射用头孢哌酮钠舒巴坦(1∶1)中细菌内毒素,方法简便、切实可行。
Objective To determine the feasibility of the preliminary screening test in the determination ot cefoperazone sodium and sulbactam sodium for injection. Methods According to the Chinese Pharmacopoeia （edition 2005）,the disturbance experiment and limited amount test of bacterial endotoxins with tachypleus amebocyte lysate （TAL） were performed. Results Use of 0. 25 EU/mL TAL and increase of the dilution times could eliminate the disturbance of cefoperazone preliminary screening test can be used in bacterial endotoxin test sodium and sulbactam sodium for injection with TAL. Conclusion The （BET） of cefoperazone sodium and sulbactam sodium for injection.
出处
《中国药业》
CAS
2008年第3期18-19,共2页
China Pharmaceuticals
关键词
注射用头孢哌酮钠舒巴坦(1:1)
细菌内毒素
鲎试剂
初筛法
cefoperazone sodium and sulbactam sodium for injection
bacterial endotoxin
TAL
preliminary screening test
