穿琥宁注射液内毒素检查方法研究  

The Researches on the Feasibility for the Bacterial Endotoxin Inspection Method of Potassium Dehydroandrographolide Succinate Injection

作　　者：陈君 

机构地区：[1]襄阳市食品药品监督检验所,湖北襄阳441100

出　　处：《中医药导报》2015年第12期29-31,共3页Guiding Journal of Traditional Chinese Medicine and Pharmacy

摘　　要：目的:考察穿琥宁注射液的细菌内毒素检查法的可行性,以代替热原检查法。方法:按《中国药典》(2010年版二部)附录细菌内毒素检查法。结果:穿琥宁注射液经过30倍稀释后,对鲎试剂的凝聚反应无干扰作用,选用标示灵敏度为0.5 EU/m L的鲎试剂检测细菌内毒素的方法可行,有效。结论:可以采用细菌内毒素检查法代替家兔法检测穿琥宁注射液的热源检查。Objective： To study the feasibility for the bacterial endotoxin inspection method of Potassium Dehydroandro- grapholide Succinate Injection, to replace the method of the pyrogen test. Method： The author carried out the bacterial endotoxin test according to the method in appendix of Chinese Pharmacopoeia （2010 cdition, sccond part）. Results： There was no interfer- ence effect of Potassium Dehydroandrographolide Succinate Injection on the agglutination reaction of tachypleus amebocyte lysate （TAL）, and the method of using 0.5 EU/mL dose of TAL to test bacterial endotoxin was capable and efficient. Conclusion： The domestic rabbit method can be replaced by the bacterial endotoxin inspection method.

关 键 词：穿琥宁注射液 细菌内毒素 鲎试剂 干扰试验 

分 类 号：R283[医药卫生—中药学]