注射用泮托拉唑钠细菌内毒素的检查法

目的：对注射用泮托拉唑钠进行细菌内毒素检查,建立其细菌内毒素检查方法。方法：根据《中国药典》2005年版二部附录收载的细菌内毒素检查方法,用两个厂家的鲎试剂对注射用泮托拉唑钠进行干扰试验。结果：将注射用泮托拉唑钠经10倍稀释后能消除干扰因素,可用标示灵敏度为0.5 EU.mL^-1的鲎试剂进行细菌内毒素检查。结论：采用细菌内毒素检查法替代家兔热原检查法,对注射用泮托拉唑钠进行热原质量控制。

Bacterial endotoxin test in pantoprazole sodium for injection

Objective: To study the bacterial endotoxin test of pantoprazole sodium for injection. Methods: According to China Pharmacopoeia 2005, different products of tachypleus amebocyte lysate (TAL) were used for the investigation of disturbing and bacterial endotoxin test. Results: The interference between the sample and relative TAL was eliminable when the sample was diluted below 1:10 and the sensitivity of TAL was 0.5 EU·mL^-1. Conclusion: The bacterial endotoxin in the sample can be examined by limulus test instead of pyrogen test in rabbits.