摘要
目的建立门冬氨酸鸟氨酸注射液细菌内毒素检查方法。方法按《中国药典》2010年版二部附录细菌内毒素检查法,采用2个不同厂家的鲎试剂对门冬氨酸鸟氨酸注射液进行研究。结果根据临床实际应用情况,确定门冬氨酸鸟氨酸注射液的内毒素限值L=10 EU/mL;本品稀释20倍以后,对细菌内毒素检查无干扰;按拟定标准检验,该品种2个厂家6批样品细菌内毒素检查结果和家兔热原检查结果均符合规定。结论细菌内毒素检查法可代替家兔热原检查法用于门冬氨酸鸟氨酸注射液的质量控制。
Objective To establish bacterial endotoxin test method for ornithine aspartate injection. Methods The ex- periment was carried out according to the bacterial endotoxin test method indexed in the Appendix H of Chinese Pharmacopeia （2010 edition, 2 volume） Tachypleus amabocyte lysate from two manufacturers were used to test bacterial endotoxin of ornithine aspartate injection. Results According the dose of clinical medication to determine the most suitable limit of bacterial endotoxin in preparations for ornithine aspartate injection was 10 EU/mL. After dilution for 20 times, ornithine aspartate injection showed no interference in the bacterial endotoxin test. The results of bacteria endotoxin tests and rabbit pyrogen tests in 6 batchs of samples from two manufacturers were all up to the standards of the quality control. Conclusion The bacterial endotoxin test method can be applied in the quality control replacing the rabbit pyrogen test method.
出处
《中国医药导报》
CAS
2013年第6期100-101,104,共3页
China Medical Herald
基金
安徽省食品药品监督管理系统科研项目(项目编号:0004)
