注射用还原型谷胱甘肽钠细菌内毒素检查法研究

Study on Bacterial Endotoxin Test in Reduced Glutathione Sodium for Injection

目的建立注射用还原型谷胱甘肽钠的细菌内毒素检查法。方法按照2010年版《中国药典(二部)》附录ⅪE细菌内毒素检查法,对3批样品进行干扰试验和细菌内毒素检查。结果用灵敏度λ为0.5 EU/mL的鲎试剂,当注射用还原型谷胱甘肽钠的质量浓度为8.0 g/L时,供试品不干扰鲎试剂与细菌内毒素的凝集反应。结论建立的注射用还原型谷胱甘肽钠细菌内毒素检查法可行。

Objective To establish a method for the detection of bacterial endotoxin in Reduced Glutathione Sodium for Injection.Methods Three batch of samples were used for the experiment of interference test and bacterial endotoxin test in accordance with appendix ⅪE,volume two,China Pharmacopoeia 2010 edition.Results By using tachypleus amebocyte lysates whose sensitivity was 0.5 EU/mL,the sample did not interfere the congregating reactivity of tachypleus amebocyte lysate with bacterial endotoxin when the concentration of reduced glutathione sodium was below 8.0 g/L.Conclusion The method of bacterial endotoxin test is feasible for the Reduced Glutathione Sodium for Injection.