摘要
目的:建立依地酸二钠细菌内毒素的常规检测方法。方法:根据《中国药典》2015年版四部通则1143细菌内毒素检查法,采用动态浊度法对依地酸二钠进行干扰预试验和正式干扰试验,确定依地酸二钠的不干扰稀释倍数或不干扰稀释浓度。结果:用BET水溶解配制成初始浓度为50 mg·mL^-1的供试品溶液,采用钙离子缓冲液稀释50倍,再用BET水稀释2倍进行定量检测。结果无干扰因素影响,内毒素回收率在50%~200%范围内。结论:动态浊度法可用于检测依地酸二钠中的细菌内毒素含量。
Objective:To establish aroutine test method of bacterial endotoxin for disodium edetate.Methods:The bacterial endotoxin test was carried out according to the general rule 1143 of Chinese Pharmacopoeia 2015 Vol IV.The kinetic turbidimetric method was used to conductpre-interference test and interference test on disodium edetateto confirm the non-interference dilution ratio or non-interference dilution concentration of the sample.Results:The test solution with initial concentration of 50 mg·mL^-1 was prepared with BET water.The initial solution was diluted 50 times with calcium ion buffer,then diluted 2 times with BET water for quantitative determination.There was no inference and the recovery rate of endotoxin fell into 50%-200%.Conclusion:Kinetic turbidimetricassaycan be usedfor determination of bacterial endotoxinin disodium edetate.
作者
王尧尧
顾德周
王贺
杨晨
何跃芳
王林
WANG Yaoyao;GU Dezhou;WANG He;YANG Chen;HE Yuefang;WANG Lin(Yangtze River Pharmaceutical Group Co.,Ltd.,Taizhou 225321,China)
出处
《中国药品标准》
CAS
2019年第6期495-499,共5页
Drug Standards of China
关键词
依地酸二钠
细菌内毒素
动态浊度法
disodium edetate
bacterial endotoxin
kinetic turbidimetric method
