单硝酸异山梨酯氯化钠注射液细菌内毒素检查法的研究

Detection of bacterial endotoxin in Isosorbide Mononitrate Sodium Chloride Injection

目的 建立单硝酸异山梨酯氯化钠注射液的细菌内毒素检查方法。方法 采用凝胶法,通过比较鲎试剂在内毒素水溶液和内毒素供试品溶液中反映的差异程度,进行干扰试验。结果 在有效稀释倍数范围内供试品对细菌内毒素检查无干扰。结论 选用标示灵敏度为 0 12 5EU·ml-1的鲎试剂可检测单硝酸异山梨酯氯化钠注射液的细菌内毒素。

Objective To establish a method for detection of bacterial endotoxin in Isosorbide Mononitrate Sodium Chloride Injection.Methods Gel-clot techniqu e introduced in the Chinese Pharmacopoeia 2000 edition was consulted.Results The Isosorbide Mononitrate Sodium Chloride Injection,d issolved with effective times of water,had no interference influence on tachypleus amebocyte lysate in detecting bacterial endotoxin.Conlusion It is feasible to tes t the bacterial endotoxin in the Isosorbide Mononitrate Sodium Chloride Injection by tachypleus amebocyte lysate with a sensitivity of 0.125EU·ml -1 .