维库溴铵细菌内毒素检测方法验证  

Validation of bacterial endotoxin test for vecuronium bromide

作　　者：孔霞[1] 王贺 王林[1] KONG Xia;WANG He;WANG Lin(Yangtze River Pharmaceutical Group Co.,Ltd.,Taizhou 225321,China)

机构地区：[1]扬子江药业集团,江苏泰州225321

出　　处：《中国药品标准》2020年第6期544-549,共6页Drug Standards of China

摘　　要：目的:建立维库溴铵细菌内毒素的常规检测方法。方法:按《中国药典》2015年版通则1143细菌内毒素检查法进行,采用不同厂家的鲎试剂对不同批号的维库溴铵分别进行干扰试验。结果:在验证条件下,供试品用稀释剂Ⅰ溶解制备成10 mg·mL^-1,并用稀释剂Ⅰ稀释至1 mg·mL^-1后再用BET水稀释至0.202 mg·mL^-1,对细菌内毒素检查法无干扰作用。结论:建立的方法用于检查维库溴铵的细菌内毒素可行。Objective:To establish a bacterial endotoxin test method for vecuronium bromide.Methods:The bacterial endotoxin test was carried out according to general chapters 1143 of the Chinese Pharmacopoeia 2015.The interference test of different batches of vecuronium bromide from different TAL manufacturers was performed.Results:Under the validation condition,the sample was dissolved to 10 mg·mL^-1 with diluentⅠ,and the solution was diluted to 1 mg·mL^-1 with diluentⅠ,then the solution was diluted to 0.202 mg·mL^-1 with water for BET.There was no interference for bacteria endotoxin test at the concentration of 0.202 mg·mL^-1.Conclusion:The established method is applicable to bacterial endotoxin test of vecuronium bromide.

关 键 词：维库溴铵 细菌内毒素 凝胶法 干扰试验 

分 类 号：R921.2[医药卫生—药学]