摘要
目的研究注射用炎琥宁对细菌内毒素检查试验的干扰情况,建立其细菌内毒素限量及检查方法。方法按《中国药典》2010年版二部附录ⅪE进行实验,采用细菌内毒素凝胶法,用2个厂家的鲎试剂对3批注射用炎琥宁进行干扰试验和结果的判断。结果注射用炎琥宁最大不干扰浓度为0.33 mg/ml,即需要稀释240倍对测定不产生干扰。结论注射用炎琥宁细菌内毒素限值确定为0.75 EU/mg,可采用凝胶法应用鲎试剂进行细菌内毒素检查。
Objective To study the interference to bacterial endotoxin test from Potassium Sodium Pehydroandrographolide Succinate for Injection,and estsblish a method of the limits and detection of bacterial endotoxin. Methods The experiment was performed according to Appendix Ⅺ E of Chinese Pharmacopeia（2010 edition,2 volume）,interference experiment and result analysis were made in three batch samples of Potassium Sodium Pehydroandrographolide Succinate for Injection,in which bacterial endotoxin method of gelation assay was used by tachypleus amebocyte lysate（TAL） from two different manufacturers. Results The maximum noninterference concentration of Potassium Sodium Pehydroandrographolide Succinate for Injection was 0.33 mg/ml,which meaned the inhibition effect could be eliminated by diluting to 240 times. Conclusion The bacterial endotoxin test can be used to detect the endotoxins in Potassium Sodium Pehydroandrographolide Succinate for Injection and the bacterial endotoxin limit is 0.75 EU/mg.
出处
《中国当代医药》
2015年第24期95-97,共3页
China Modern Medicine
关键词
注射用炎琥宁
细菌内毒素
凝胶法
鲎试剂
干扰试验
Potassium Sodium Pehydroandrographolide Succinate for Injection
Bacterial endotoxin
Gelation assay
Tachypleus amebocyte lysate
Interference test
