卡络磺钠氯化钠注射液的细菌内毒素检查法的建立  

Establishment of the Quality Standard for Bacterial Endotoxins Test of Carbazochrome Sodium Sulfonate Injection

作　　者：焉媛媛[1] 曹殿胜 丁晓飞[1] 

机构地区：[1]辽宁省食品药品检验所,沈阳110023 [2]丹东医创药业有限责任公司,辽宁丹东118000

出　　处：《中国现代应用药学》2007年第z2期714-715,共2页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立卡络磺钠氯化钠注射液的细菌内毒素检查的方法。方法按《中国药典》2000年版(二部)附录收载的细菌内毒素检查方法及指导原则进行实验。结果将卡络磺钠氯化钠注射液经2倍稀释可消除干扰因素,用标示灵敏度为0.25EU.mL-1的鲎试剂检测细菌内毒素是有效的。结论可以用细菌内毒素检查法代替家兔法控制卡络磺钠氯化钠注射液的质量。OBJECTIVE To establish the quality standard for the bacterial endotoxins test of carbazochrime sodium sulfonate injection.METHODS The experiments were carry out according to CP2000(second version). RESULTS The interference factor could be eliminated by diluting carbazochrime sodium sulfonate injection one times,and it is feasible to test the bacterial endotoxins by using TAL(0.25 EU·mL-1).CONCLUSION The bacterial endotoxins test method for carbazochrime sodium sulfonate injection can replace the test for pyrogens.

关 键 词：卡络磺钠氯化钠注射液 细菌内毒素 家兔法 

分 类 号：R973.1[医药卫生—药品]