单硝酸异山梨酯注射液细菌内毒素检查法研究

目的：建立单硝酸异山梨酯注射液细菌内毒素检查方法。方法：参照《中国药典》2005年版二部附录收载的细菌内毒素检查法及其原则进行实验,用两个不同厂家的鲎试剂对不同批号的单硝酸异山梨酯注射液进行了干扰试验和细菌内毒素检查。结果：本品稀释至0.02mg/ml时可消除对鲎试剂与细菌内毒素凝集反应的干扰,按拟定标准,9个厂家生产的22批单硝酸异山梨酯注射液均符合规定。结论：本方法可用于单硝酸异山梨酯注射液的细菌内毒素检查。

Study on the method of bacterial endotoxin test of Isosorbide Mononitrate Injection

Objective：To establish the bacterial endotoxin test methed in Isosorbide Mononitrate Injection. Methods：Ac cording to China Pharmacopoeia 2005 version （Ⅱ） appendix,different batches of Isosorbide Injection from the two different TAL manufacturers were underwent the interference tests. Results：There was no interference in the bacterial endotoxins test when the concentration of Isosorbide Mononitrate Injection was less than or equal to the detection limit 0.02 mg/ml. Conclusion：The method is feasible to carry out the bacterial endotoxin test for Isosorbide Mononitrate Injection.