动态浊度法测定注射用阿魏酸钠中细菌内毒素含量  

Determination of Bacterial Endotoxin in Sodium Ferulate for Injection by Kinetic Turbidimetric Assay

作　　者：林雄 许娇红 LIN Xiong;XU Jiao-hong(Fujian Wuyishan City Hospital,Wuyishan 354300,China;Fujian Institute for Drug Control,Fuzhou 350001,China)

机构地区：[1]福建省武夷山市立医院,福建武夷山354300 [2]福建省食品药品质量检验研究院,福建福州350001

出　　处：《海峡药学》2024年第12期47-49,共3页Strait Pharmaceutical Journal

摘　　要：目的探讨用动态浊度法定量检测注射用阿魏酸钠中细菌内毒素的含量。方法使用两个不同厂家提供的动态浊度法鲎试剂来建立标准曲线,在3批注射用阿魏酸钠中添加不同浓度的内毒素标准品,然后使用已建立的标准曲线来检测其回收率。根据干扰试验和定量检测的结果,分析注射用阿魏酸钠中细菌内毒素的回收率,并与标准曲线进行比较,对其进行定量检测。结果两个生产厂家提供的动态浊度法鲎试剂在建立细菌内毒素标准曲线时,展现出高度的线性关系,其相关系数R^(2)均超过了0.980,满足了药典的规定。样品在较高浓度(0.50 mg·mL^(-1))至较低浓度(0.0625 mg·mL^(-1))的范围内,均未显示出对细菌内毒素检测的干扰,确保了试验结果的可靠性。结论采用动态浊度法检测注射用阿魏酸钠中细菌内毒素含量检测灵敏度及准确度高、数据可靠。OBJECTIVE To determine the content of bacterial endotoxin in sodium ferulate for injection by kinetic turbidimetric assay.METHODS The standard curve of bacterial endotoxin was established by dynamic turbidimetric limulus reagent from two manufacturers.Interference test was performed on 3 batchers of sodium ferulate for injection.The recovery rate of bacterial endotoxin at different concentrations was analyzed and the method was verified.RESULTS The standard curves of limulus reagents from the two manufacturers met the pharmacopoeia requirements with R^(2)>0.980,and the recovery rates of bacterial endotoxin were within the standard range when the samples were 0.50,0.25,0.125,0.0625 mg·mL^(-1),and there was no interference,which met the requirements of pharmacopoeia.CONCLUSION The dynamic turbidity method was used to detect bacterial endotoxin in sodium ferulate for injection with high sensitivity,high accuracy and reliable date.

关 键 词：注射用阿魏酸钠 动态浊度法 干扰试验 

分 类 号：R927[医药卫生—药学]