硫酸软骨素注射液细菌内毒素检查方法研究  

Study on Bacterial Endotoxin Test for Chondroitin Sulfate Injection

作　　者：嵇扬[1] 高锦[1] 王文俊[1] 胡丹[1] 沈娟[1] 聂渝琼[1] 

机构地区：[1]总后勤部卫生部药品仪器检验所药理室,北京100071

出　　处：《食品与药品》2009年第5期34-37,共4页Food and Drug

摘　　要：目的建立检查硫酸软骨素注射液细菌内毒素的方法。方法用中国药典2005年版附录细菌内毒素检查法。结果硫酸软骨素注射液浓度0.025mg/mL,用灵敏度0.125EU/mL的鲎试剂检测细菌内毒素无干扰因素的影响。结论硫酸软骨素注射液可用鲎试剂检查细菌内毒素。Objective To establish a detection method for bacterial endotoxin in Chondroitin Sulfate Injection. Methods The bacterial endotoxin test in the appendix of Chinese Pharmacopoeia （2005 edition） was adopted. Results The maximum noninterference concentration was 0.025mg·mL-1 and the sensitivity of TAL was 0.125 Eu.mL-1. Conclusion The bacterial endotoxin test is suitable for Chondroitin Sulfate Injection by TAL.

关 键 词：硫酸软骨素注射液 细菌内毒素 干扰试验 

分 类 号：Q538[生物学—生物化学]