盐酸利多卡因注射液中细菌内毒素定量检测法探究  

Quantitative Determination of Bacterial Endotoxin in Lidocaine Hydrochloride Injection by Micro-dynamic Chromogenic Method

作　　者：朱文娟 翁嘉 李锦妹 陈文静 黄永德 李红静 林凤屏 ZHU Wen-juan;WENG Jia;LI Jin-mei;CHEN Wen-jing;HUANG Yong-de;LI Hong-jing;LIN Feng-ping(Huizhou Institute for Food and Drug Control,Huizhou 516003,China)

机构地区：[1]惠州市食品药品检验所,广东惠州516003

出　　处：《海峡药学》2023年第3期17-21,共5页Strait Pharmaceutical Journal

摘　　要：目的建立盐酸利多卡因注射液中细菌内毒素定量检测方法,准确实时评估注射液中内毒素含量,并与凝胶法检测结果相比较,以确定微量动态显色法用于盐酸利多卡因注射液中细菌内毒素定量检测的可行性和准确性。方法采用微量动态显色法,选取2家不同厂家共6批样品进行实验,通过标准曲线可靠性试验、预干扰和干扰实验,确定本品不被干扰的稀释倍数,并将结果与凝胶法比较。结果标准曲线可靠性的回归方程为lgT=2.8974-0.29133lgC,相关系数|r|=1.0000,本品稀释至10倍时无干扰,回收率在60%~75%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可用于定量检测盐酸利多卡因注射液中的细菌内毒素含量,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 lidocaine hydrochloride injection,to evaluate the endotoxin content in the injection accurately and in real time,and to compare it with the detection results of the gel clot method to determine the Micro-dynamic chromogenic method for Lidocaine hydrochloride injection is feasibility and accuracy.METHODS 6 batches from 2 different manufacturers were selected for the experiment by using Micro-dynamic chromogenic method.Through the reliability test of the standard curve,the pre interference and interference test,the non interference dilution multiple of the product was determined,and the results were compared with the gel clot method.RESULTS In the reliability test of standard curve,the regression equation of the curve was lgT=2.8974-0.29133lgC,the correlation coefficient of|r|was 1.0000.No interference was detected at dilution factor of 10,the recovery rates was within 60%to 75%.The results of Micro-dynamic chromogenic method and gel clot method were consistent.CONCLUSION The Micro-dynamic chromogenic method can be used to quantitatively detect the bacterial endotoxin content in Lidocaine Hydrochloride Injection.Compared with the gel clot method,the operation is more convenient and fast,and quantitative detection can be achieved with higher sensitivity.

关 键 词：盐酸利多卡因注射液 微量动态显色法 细菌内毒素 定量检测 凝胶法 

分 类 号：R927[医药卫生—药学]