摘要
目的:建立尼扎替丁注射液细菌内毒素的检查方法。方法:用不同厂家、不同批号、不同灵敏度的鲎试剂对尼扎替丁注射液进行干扰实验。结果:用标示灵敏度为0.25 EU·ml-1的鲎试剂,尼扎替丁注射液稀释2倍后,对细菌内毒素检查无干扰作用。结论:可以用细菌内毒素检查法取代尼扎替丁注射液的热原检查。
Objective：To establish bacterial endotoxin test for nizatidine injection using tachypleus a mebocyte lysate. Methods： The interferential test of nizatidine injection were studied using tachypleus amebocyte lysate of different factories,different batch numbers and different sensitivities. Results：When the tachypleus amebocyte lysat＇sensitivity is 0.25 EU· ml^-1 and maximum valid dilution is 2, the bacterial endotoxins test isn＇t interferential.Conclusion：The bacterial endotoxins test of nizatidine injection can be replaced by the pyrogen test of it.
出处
《现代医药卫生》
2008年第17期2554-2556,共3页
Journal of Modern Medicine & Health
关键词
鲎试剂
细菌内毒素
尼扎替丁注射液
Nizatidine injection
Tachypleus a mebocyte lysate
Bacterial endotoxin test
