建立血栓通冻干粉针细菌内毒素检查方法

摘要

Objective To establish a method for Bacterial Endotoxin Test of Xueshuantong Freeze - drying powder. Methods Detection was carried out according to the principle and procedure in China Pharmacopeia,2000 edition. Results Xueshuantong injection did not interfere with 4mg/ ml concentration. Conclusion Bacterial Endotoxin Test could be use in Xueshuantong Freeze - drying powder.%目的：建立血栓通冻干粉针细菌内毒素检查方法。方法依照《中国药典》2015年版（四部）附录方法和指导原则，建立血栓通冻干粉针细菌内毒素检查方法。结果血栓通冻干粉针在4mg/ ml 的浓度对细菌内毒素检查结果没有影响。结论细菌内毒素检测方法可用于血栓通冻干粉针的热原检查。