【摘要】 目的　考察精氨酸注射液细菌内毒素检查法的可行性。方法　依照《中国药品检验标准操作规程》2 0 0 0年版细菌内毒素检查法 ,确定精氨酸注射液的有效稀释浓度和细菌内毒素限值。结果　精氨酸注射液在最大有效稀释浓度下对鲎试剂无干扰作用 ,其内毒素限值符合规定。结论　可用细菌内毒素检查法来取代《中国药典》2 0 0 0年版 (二部 )规定的热原检查法更多还原

【Abstract】 AIM To investigate feasibility of bacterial endotoxins on arginine injection. METHODS The valid concentration of arginine injection and it’s bacterial endotoxin limit were determined by the principle of bacterial endotoxin test method. RESULTS The experiment showed that the interferenceelements can be excluded by diluting arginine injection 2 times, and it is effective that endotoxin can be tested by amebocyte lysate with accualy of 0 5 Eu·ml -1 . CONCLUSION Bacterial endotoxin test can be used to replace the pyrogen test which is set departmental standard.更多还原