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。

    关键词：硫酸软骨素A钠注射液；细菌内毒素；干扰试验

    中图分类号：R927.11文献标识码：A文章编号：1672-979X(2008)11-0024-03

    Study on Bacterial Endotoxin Test for Chondroitin Sulfate A Sodium Injection

    JI Yang, GAO Jin, SHEN Juan, WANG Wen-Jun, HU Dan, NIE Yu-Qiong

    (Institute for Drug and Instrument Control of Health Department GLD of PLA, Beijing 100071, China)

    Abstract：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. ......