摘要
目的对骨瓜提取物注射液进行鲎试剂检查法实验,以替代热原检查,建立骨瓜提取物注射液细菌内毒素检查法。方法参照《中国药典》2005版(二部)附录X IE实验方法,通过干扰实验来确定骨瓜提取物注射液的有效稀释浓度和细菌内毒素检查限值。结果骨瓜提取物注射液的40倍稀释溶液无干扰作用,其内毒素限值符合规定。结论骨瓜提取物注射液可以通过细菌内素检查法来控制细菌内毒素含量。
Aim To establish bacterial endotoxin test method of the extraction of bone-melon injection. Method The test was carried out according to the guideline of interfering test and procudure specified in Chinese Pharmacopeia 2005. Result The injection did not interfere with limukus agent in 40 diluted concentration. Conclusion Bacterial endotoxin test can be used for the extraction of bone-melon injection.
出处
《安徽医药》
CAS
2007年第12期1091-1092,共2页
Anhui Medical and Pharmaceutical Journal
关键词
骨瓜提取物注射液
细菌内毒素
鲎试剂
extraction of bone-melon injection
bacterial endotoxin
limulus agent
