注射用泮托拉唑钠的细菌内毒素检查

Determination of bacterial endotoxin in Pantoprazole Sodium for Injection

目的建立注射用泮托拉唑钠细菌内毒素的检查方法。方法按《中国药典》2005年版(二部)附录ⅪE进行实验和结果判断。结果用标示量灵敏度0.25EU.mL-1的鲎试剂,注射用泮托拉唑钠的有效检测浓度为0.13mg.L-1,3批注射用泮托拉唑钠内毒素均小于1.88EU.mL-1。结论本品可以用细菌内毒素检查法代替家兔热源检查法。

OBJECTIVE To establish the method of bacterial endotoxin determination for Pantoprazole Sodium for Injection.METHODS The experiment and the judgment of its result were made according to the appendix Ⅺ E of Chinese Pharmacopeia 2005 Vol Ⅱ.RESULTS The valid concentration of Pantoprazole Sodium for Injection was 0.13mg·mL^-1 with 0.25EU·mL^-1 sensitivity of TAL,and the endotoxin content was less than 1.88EU·mL^-1 in each of 3 lots.CONCLUSION Bacterial endotoxin text can be used in place of rabbit pyrogen text for Pantoprozole Sodium for Injection.