注射用水溶性维生素细菌内毒素检查法质量标准研究Ⅱ  

study on bacterial endotoxin test for Water - soluble Vitamin for Injection Ⅱ

作　　者：张德波[1] 莫书蓉[2] 

机构地区：[1]成都市食品药品检测中心,610045 [2]成都中医药大学药学院

出　　处：《内蒙古中医药》2011年第3期131-132,共2页Inner Mongolia Journal of Traditional Chinese Medicine

摘　　要：目的:在现行的国家标准的基础上对注射用水溶性维生素细菌内毒素检查法进行再研究。方法:按中国药典二部细茵内毒素检查法考查本品不使用缓冲液配制供试液对内毒素与鲎试剂反应的干扰情况。结果:本品供试液配制不使用缓冲液完全可行。结论:注射用水溶性维生素细菌内毒素检查可以直接使用BET水配制供试液,而不需要使用缓冲液。Objective： On the basis of the national standard, we have studied on test for Watersoluble Vitamin for Injection .Methods： It was used BET water and not the modulatory liquor to confect the test solution to studied the interference on bacterial endotoxius test. Results： It was not interference on bacterial endotoxin test that the test solution used BET water to confect. Conclusion： The test solution of Watersoluble Vitamin for Injection can use the BET water to confect and not use the modulatory liquor.

关 键 词：注射用水溶性维生素 细菌内毒素检查 缓冲液 干扰试验 

分 类 号：F921.2[经济管理]