血必净注射液细菌内毒素检查法的考察

Bacterial Endotoxin Test of Xuebijing Injection

目的为保证血必净注射液的临床用药安全,探讨建立血必净注射液细菌内毒素检查方法。方法按中国药典2005年版附录细菌内毒素检查法要求进行试验。结果血必净注射液稀释6倍(浓度为0.167)及以上时,不干扰鲎试剂与细菌内毒素的凝胶反应。结论细菌内毒素检查法可用于检测血必净注射液中的细菌内毒素。

Aim To establish a method using tachypleus amebocyte lysate （TAL） for testing the bacterial endotoxin in Xuebijing Injection in order to ensure the safe clinic application of Xuebijing Injection. Methods The tests were conducted according to appendix IX E of Chp 2005. Results Neither inhibition nor enhancement was found in the bacterial endotoxin test after the drug （Potassium Sodium pehydroandroandrographolide Succinate for Injection 0. 167 mg·ml^-1） was diluted to 6. Conclusion Bacterial endotoxin test can be used for the detection of bacterial endotoxin in Potassium Sodium pehydroandroandrographolide Succinate for Injection.