摘要
目的 建立检测注射用亚叶酸钠中内毒素的试验方法。方法 采用《中国药典》2 0 0 0年版附录细菌内毒素检查法。结果 注射用亚叶酸钠在药液稀释浓度 0. 5 5mg·ml-1以下时 ,与鲎试剂反应无干扰。结论 用细菌内毒素检查法检查注射用亚叶酸钠中的内毒素可行。
OBJECTIVE To establish a method for testing the bacterial endotoxins in Sodium folinate injection. METHODS The assay method was established according to the bacterial endotoxin test and eliminated interfere factors approved by Chinese pharmacopoeia 2000 edition. RESULTS Endotoxin added to Sodium folinate injection was recovered in quantitative manner showing neither inhibition nor enhancement when the injection was diluted to the concentration lower than 0.55 mg·ml -1.CONCLUSION These results suggest that the bacterial endotoxin test is suitable for the detection of endotoxin in Sodium folinate injection.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2005年第1期73-74,共2页
West China Journal of Pharmaceutical Sciences