动态显色法检测紫杉醇注射液中细菌内毒素含量的微量检测方法研究
Determination of bacterial endotoxin in paclitaxel injection by dynamic chromogenic method detection method research
严晶 1耿铮 1车慧 1何丽娟1
作者信息
- 1. 北京协和药厂有限公司,北京 100000
- 折叠
摘要
目的 建立微量动态显色法测定紫杉醇注射液中细菌内毒素含量的方法.方法 依据《中国药典》2020年版四部通则1143细菌内毒素检查法中的要求,在Epoch 2 NS酶标仪上对紫杉醇注射液细菌内毒素的光度测定方法进行研究和开发.通过微量动态显色法鲎试剂的可靠性试验和干扰试验预试验确定有效的稀释倍数,再取三批紫杉醇注射液进行干扰试验,测定回收率并对三批样品进行细菌内毒素的检验.结果 标准曲线可靠性试验中,鲎试剂标准曲线的相关系数|r|均大于0.980;供试品稀释150、300、450倍时,对测定均无干扰;采用三批样品分别使用两个厂家的鲎试剂进行干扰试验,回收率均在50%-200%的范围内,三批样品的细菌内毒素结果均低于限度值.结论 微量动态显色法可用于紫杉醇注射液细菌内毒素的定量检验.
Abstract
Objective To establish a method for the determination of bacterial endotoxin in paclitaxel injection by dynamic chromogenic method.Methods According to the requirements of bacterial endotoxin test method in the fourth General Rule 1143 of the 2020 edition of Pharmacopoeia of the People's Republic of China,A photometric method for the determination of bacterial endotoxin in Paclitaxel Injection was studied and developed on Epoch 2 NS.The effective dilution factor was determined by reliability test of limulus agent and interference test pre-experiment of micro-dynamic chromogenic method.Then three batches of paclitaxel injection were taken for interference test,the recovery rate was determined,and bacterial endotoxin was detected.Results In the reliability test of standard curve,the correlation coefficients of limulus agent standard curve|r|are greater than 0.980.When the test product was diluted 150,300,450 times,there was no interference to the determination.Three batches of samples were used for interference tests with limulus reagents from two manufacturers respectively.The recoveries were in the range of 50%-200%.The results of bacterial endotoxin in three batches of samples were all below the limit value.Conclusion Micro-dynamic chromogenic method can be used for quantitative determination of bacterial endotoxin in paclitaxel injection.
关键词
紫杉醇注射液/细菌内毒素/微量动态显色法/干扰试验Key words
Paclitaxel Injection/Bacterial endotoxins/Micro-dynamic chromogenic method/Interference test引用本文复制引用
出版年
2025
NETL
NSTL
万方数据