硫酸软骨素A钠注射液细菌内毒素检查方法研究  

Study on Bacterial Endotoxin Test for Chondroitin Sulfate A Sodium Injection

作　　者：嵇扬[1] 高锦[1] 沈娟[1] 王文俊[1] 胡丹[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》2008年第6期24-26,共3页Food and Drug

摘　　要：目的建立检查硫酸软骨素A钠注射液细菌内毒素的方法。方法采用中国药典2005年版附录细菌内毒素检查法。结果硫酸软骨素A钠注射液浓度为0.15 mg.mL-1,用灵敏度为0.25 EU.mL-1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A钠注射液可用鲎试剂检查细菌内毒素。Objective To establish the detection method of bacterial endotoxin for chondroitin sulfate A sodium injection. Methods The bacterial endotoxin test method in Chinese pharmacopoeia （2005 edition） was adopted. Results The bacterial endotoxin test was performed with TAL of 0.25 EU ·mL^-1, and the maximum noninterference concentration of chondroitin sulfate A sodium injection was 0.15 mg·mL^-1. Conclusion The bacterial endotoxin can be detected by TAL in chondroitin sulfate A sodium injection.

关 键 词：硫酸软骨素A钠注射液 细菌内毒素 干扰试验 

分 类 号：R927.11[医药卫生—药学]