葡萄糖酸钙注射液中细菌内毒素的定量检测

Quantitative Determination of Bacterial Endotoxin in Calcium Gluconate Injection

目的建立葡萄糖酸钙注射液中细菌内毒素的定量检测方法,以便准确实时评估注射液中内毒素的含量变化。方法采用微量动态显色法,选取2个不同厂家共6批样品,通过标准曲线可靠性试验、预干扰和干扰实验,确定样品不被干扰的稀释倍数,并将检测结果与凝胶法进行比较。结果标准曲线可靠性回归方程为lg T=2.8974-0.29133lg C,相关系数│r│=1.0000,本品稀释至50倍时无干扰,回收率值在60%~70%之间;微量动态显色法与凝胶法检查结果一致。结论微量动态显色法相较于凝胶法,操作更方便快捷,可实现定量检测,结果灵敏度更高。

Objective To establish a quantitative detection method for bacterial endotoxin in Calcium Gluconate Injection,and to evaluate the endotoxin content in the injection accurately and in real time.Methods Micro-kinetic chromogenic method was adopted,and six batches of samples from two different manufacturers were selected for detection.Through the standard curve reliability test,pre-interference and interference experiments,the dilution ratio of the samples without interference was determined,and the test results were compared with those of the gel clot method.Results The regression equation of the standard curve was lgT=2.8974-0.29133lgC,the correlation coefficient│r│was 1.0000.No interference when the sample was diluted for 50 times;the recoveries were 60%-70%.The results of micro-dynamic chromogenic method and gel clot method were consistent.Conclusion Compared with the gel clot method,the micro-kinetic chromogenic method is more convenient and quick to operate,has higher sensitivity,and can achieve quantitative detection.