摘要
目的研究注射用甲泼尼龙琥珀酸钠的细菌内毒素标准,制订其适合国内实验室细菌内毒素的检测方法。方法根据中国药典2005年版附录细菌内毒素检查法(凝胶法)。结果注射用甲泼尼龙琥珀酸钠在药液稀释浓度0.74mg/ml以下时,与TAL试剂(灵敏度为0.25)反应无干扰因素影响。结论国内条件下可根据注射用甲泼尼龙琥珀酸钠国外厂家提供的标准对其进行有效质量控制。
Objective To study the injection by a nylon sodium succinate Takizawa of bacterial endotoxin standards,formulating its national laboratory for bacterial endotoxin detection method . Method According to the Chinese Pharmacopoeia 2005 version of Appendix bacterial endotoxin test （gel）. Results A Long nylon injection in the liquid sodium succinate diluted concentration of 0. 74 mg/ ml following, and TAL reagent （sensitivity of 0. 25） reaction without interference factors. Conclusion The domestic conditions for injection under a waterfall nylon sodium succinate foreign manufacturers to provide its standard for effective quality control.
出处
《中国实用医药》
2009年第12期84-86,共3页
China Practical Medicine
关键词
注射用甲泼尼龙琥珀酸钠
细菌内毒素检查法
干扰试验
鲎试剂
Methylp rednisolone
Sodium Succinate for Injection
Bacterial endotoxins test
Interfere factors test
Limulus lysate agent
