维生素B_(12)注射液细菌内毒素动态浊度法检验方法的建立  

Establishment of Kinetic Turbidimetric Assay for Bacterial Endotoxin in Vitamin B_(12) Injection

作　　者：房霞 刘晋 谢海真 王芳芳 徐婉婷 FANG Xia;LIU Jin;XIE Haizhen;WANG Fangfang;XU Wanting(Liaocheng Municipal Inspection and Testing Center,Shandong Liaocheng 252000,China)

机构地区：[1]聊城市检验检测中心,山东聊城252000

出　　处：《中国医药导刊》2025年第2期162-165,共4页Chinese Journal of Medicinal Guide

基　　金：2023年山东省药品安全风险监测项目维生素B12注射液专项(202315)。

摘　　要：目的:研究建立动态浊度法检测维生素B_(12)注射液中细菌内毒素含量的方法,以提高产品质量控制水平并保障临床用药安全。方法:依据2020年版《中华人民共和国药典》<1143细菌内毒素检查法>的要求,应用Pyros Kinetix^(R)Flex 96(PKF 96)细菌内毒素定量检测系统,使用无热源水稀释溶解鲎试剂(LAL),建立细菌内毒素的标准曲线并确定稀释倍数,通过测定供试品溶液中外加内毒素的回收率进行干扰试验,并定量测定样品中的细菌内毒素含量。结果:内毒素检测标准曲线浓度线性范围为0.005~5.0 EU·m L^(-1)(r=-0.993),标准曲线回归方程为log T=-0.288log C+2.81;供试品在稀释4、8、16倍时均对试验无干扰作用,细菌内毒素回收率为50%~200%;57批样品的内毒素定量测定结果符合规定。结论:在细菌内毒素定量检测系统平台建立的动态浊度法,可用于维生素B_(12)注射液的细菌内毒素定量检测。该方法的建立不仅符合法规要求,还为加强注射液质量控制、保障临床安全使用提供了重要的技术支持。Objective:To improve product quality control and ensure clinical medication safety,this study established a kinetic turbi-dimetric assay for detecting bacterial endotoxin level in vitamin B12 injection.Methods:According to the requirements of the"1143 Bac-terial Endotoxin Test Method"in the 2020 edition of the Pharmacopoeia of the People's Republic of China,the Pyros Kinetix^(R)Flex 96(PKF 96)bacterial endotoxin quantitative detection system was utilized and non-pyrogenic water was used to dilute and dissolve Limulus Amebocyte Lysate(LAL),establishing a standard curve for bacterial endotoxins and determining the dilution factor.Interference tests were performed by measuring the recovery rate of spiked endotoxins in the test solution,allowing for the quantitative determination of bac-terial endotoxin content in the samples.Results:The linear range of the endotoxin detection standard curve was 0.005 to 5.0 EU·mL^(-1)(r=-0.993),with the regression equation logT=-0.288logC+2.81.The test samples showed no interference when diluted by 4,8,and 16 times,and the bacterial endotoxin recovery rates were within the 50% to 200% range.The endotoxin quantification results from 57 batches of samples were found to be compliant with the requirements.Conclusion:The kinetic turbidimetric assay established on the platform of the bacterial endotoxin quantitative detection system is applicable for the quantitative detection of bacterial endotoxins in vita-min B12 injections.The establishment of this method not only meets regulatory requirements but also provides significant technical sup-port for strengthening the quality control of injections and ensuring their safe clinical use.

关 键 词：维生素B_(12)注射液 动态浊度法 细菌内毒素 最大有效稀释倍数 干扰试验 

分 类 号：R917[医药卫生—药物分析学]