摘要
目的:建立注射用硫普罗宁细菌内毒素检查方法。方法:参照《中国药典》2010年版二部细菌内毒素检查法进行试验。结果:将硫普罗宁稀释至1 mg·mL-1时对细菌内毒素和鲎试剂的反应无干扰作用。结论:该品种可采用细菌内毒素检查法控制药品质量。
Objective： To establish a bacterial endotoxin test method for Tiopronin for Injection. Methods ： Experiment was carried out according to the test for bacterial endotoxin in appendices XI E of Ch. P. （2010） Volume Ⅱ. Results： At the concentration of 1 mg mL-1 ,Tiopronin has no interferential effects on the gelatin reaction of bacterial endotoxin with Tachypleus Amebocyte Lysate. Conclusion ： Endotoxin test method can be adopted on the quality control of Tiopronin for Injection.
出处
《中国药品标准》
CAS
2012年第3期203-205,共3页
Drug Standards of China
关键词
注射用硫普罗宁
细菌内毒素检查
干扰试验
Tiopronin for Injection
bacterial endotoxin test
disturbance test
