钠钾镁钙葡萄糖注射液细菌内毒素两种不同检测方法研究  

Study on Two Different Methods for Detecting Bacterial Endotoxin in Sodium Potassium Magnesium Calcium and Glucose Injection

作　　者：潘兴军[1] 常兴 李树馀 PAN Xing-jun;CHANG Xing;LI Shu-yu(Jiangsu Hengrui Pharmaceuticals Co.,Ltd.,Lianyungang 222000,China;Zhanjiang A&C Biological Ltd.,Zhanjiang 524022,China)

机构地区：[1]江苏恒瑞医药股份有限公司,江苏连云港222000 [2]湛江安度斯生物有限公司,广东湛江5240022

出　　处：《药物生物技术》2022年第5期474-478,共5页Pharmaceutical Biotechnology

摘　　要：文章研究凝胶限度法及动态显色法(微量)两种不同的检测方法对于钠钾镁钙葡萄糖注射液细菌内毒素检测方法及结果的影响。使用中国药典2020年版通则1143细菌内毒素检查法提到的凝胶限度法及借助全自动细菌内毒素检测系统进行的动态显色法(微量)两种检测方法对钠钾镁钙葡萄糖注射液细菌内毒素检测方法及结果进行研究及对比。使用凝胶限度法及全自动细菌内毒素检测系统动态显色法(微量)对钠钾镁钙葡萄糖注射液稀释最大8倍进行细菌内毒素检测时,干扰试验均成立,检测结果一致,均符合中国药典2020年版的要求。凝胶限度法及全自动细菌内毒素检测系统动态显色法(微量)均可用于钠钾镁钙葡萄糖注射液细菌内毒素检测,全自动细菌内毒素检测系统动态显色法(微量)在减小试验过程中的人为误差及结果定量方面优势更加明显。The effects of gel limit method and dynamic colorimetric method(trace)on the determination of bacterial endotoxin in sodium potassium magnesium calcium and glucose injection were studied.The bacterial endotoxin detection methods and results of sodium potassium magnesium calcium and glucose injection were studied and compared by using gel limit method mentioned in general rule 1143 bacterial endotoxin test method of Chinese Pharmacopoeia 2020 edition and dynamic chromogenic method(trace)with automatic bacterial endotoxin test system.When using gel limit method and automatic bacterial endotoxin test system dynamic chromogenic method(trace)for sodium potassium magnesium calcium and glucose injection dilution up to 8 times for bacterial endotoxin detection,the interference test was established,and the test results were consistent,which were in line with the requirements of Chinese Pharmacopoeia 2020 edition.Both gel limit method and dynamic chromogenic method(trace)of automatic bacterial endotoxin test system can be used for bacterial endotoxin detection of sodium potassium magnesium calcium and glucose injection.Dynamic chromogenic method(trace)of automatic bacterial endotoxin test system has more obvious advantages in reducing human error in the test process and quantitative results.

关 键 词：动态显色法(微量) 光度法 凝胶限度试验 全自动细菌内毒素检测系统 钠钾镁钙葡萄糖注射液 干扰试验预实验 干扰试验 

分 类 号：R927.12[医药卫生—药学]