三磷酸胞苷二钠注射液细菌内毒素检查方法研究

Bacterial Endotoxin Test for Cytidine Disdoium Triphosphate Injection with Tachypleus Amebocyte Lysate

目的建立三磷酸胞苷二钠注射液细菌内毒素检查法。方法根据2010版《中国药典》二部附录ⅪE细菌内毒素检查方法,用2个生产厂家的鲎试剂,进行了三磷酸胞苷二钠注射液干扰试验研究,探索本品能否应用细菌内毒素检查法代替热原检查法。结果初筛三磷酸胞苷二钠注射液无干扰浓度范围为0.033-0.264 mg/m L。0.1 mg/m L浓度的干扰试验,Es在0.5-2λ,Et在0.5-2 Es,供试品在0.1 mg/m L浓度下对内毒素检查没有干扰作用。供试品内毒素检查结果与家兔热原检查结果一致。结论三磷酸胞苷二钠注射液可用细菌内毒素检查法控制热原。

OBJECTIVE To establish a method for the detection of bacterial endotoxin in Cytidine Disdoium Triphosphate injection with bacterial endotoxin test. METHODS To examine whether Cytidine Disdoium Triphosphate injection can be detected with bacterial endotoxin inspection method,instead of pyrogen test,2 different manufacturer limulus reagents were used for interference test.The bacterial endotoxin test was conducted for Cytidine Disdoium Triphosphate injection based on the Chinese Pharmacopoeia 2010 volume Ⅱ appendix XIE. RESULTS Cytidine triphosphate disodium injection can be detected in the concentration range of 0. 033-0. 264 mg / m L without interference. There was no interference effect for Cytidine Disdoium Triphosphate injection at 0. 1 mg / m L and Es between 0. 5-2 λ,Et between 0. 5-2 Es. The results were consistent with rabbit pyrogen test. CONCLUSION The pyrogen in Cytidine Disdoium Triphosphate injection can be controlled by bacteria endotoxin test.