血液透析液中碳酸氢根检测方法的优化与改进  

Optimization and improvement of detection method for bicarbonate in hemodialysis fluid

作　　者：叶晓燕[1] 陈华燕 黄麒谕 何晓帆[1] 许朝生 梁泽鑫[1] YE Xiaoyan;CHEN Huayan;HUANG Qiyu;HE Xiaofan;XU Chaosheng;LIANG Zexin(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou,Guangdong,China,510663)

机构地区：[1]广东省医疗器械质量监督检验所,广东广州510663

出　　处：《分子诊断与治疗杂志》2023年第9期1520-1523,1529,共5页Journal of Molecular Diagnostics and Therapy

基　　金：广东省药品监督管理局科技创新项目(2018ZDZ04)。

摘　　要：目的通过研究返滴定法检测血液透析液中的碳酸氢根含量,考察该方法的可行性。方法分别采用盐酸滴定法和返滴定法检测透析液中的碳酸氢根含量。结果返滴定法检测不同配方血液透析液中的碳酸氢根含量,其精密度RSD分别为0.10%、0.17%、0.11%、0.10%、0.14%,中间精密度RSD为0.06%,稳定性结果RSD为0.05%。回收率试验中,返滴定法检测醋酸配方透析液的平均回收率结果分别为101.19%、100.70%、100.86%,检测枸橼酸配方透析液的平均回收率结果分别为100.20%、100.06%、99.93%;盐酸滴定法检测醋酸配方透析液的平均回收率结果分别为106.10%、105.47%、103.84%,检测枸橼酸配方透析液的平均回收率结果分别为102.25%、101.77%、101.62%。结论采用返滴定法检测血液透析液中碳酸氢根含量,其专属性强、稳定性好、准确度高,适用于不同配方血液透析液的检测。Objectives To investigate the viability of back⁃titration method in the measurement of bicarbonate concentration in hemodialysis fluids.Methods Hydrochloric titration method and back⁃titration method were used to determine the content of bicarbonate in dialysate.Results The back⁃titration method was used to detect the content of bicarbonate in different formulations of hemodialysate,the precision RSDs were 0.10%,0.17%,0.11%,0.10%,0.14%,the intermediate precision RSD was 0.06%,and the stability result RSD was 0.05%.In the recovery rate test,the average recoveries of dialysates formulated with acetic acid by back titration were 101.19%,100.70%,and 100.86%,and the average recoveries of dialysates formulated with citric acid were 100.20%,100.06%,and 99.93%,respectively.The average recoveries of dialysates formulated with acetic acid by hydrochloric acid titration were 106.10%,105.47%,and 103.84%,and the average recoveries of dialysates formulated with citric acid were 102.25%,101.77%,and 101.62%,respectively.Conclusions The back⁃titration method is used to detect the content of bicarbonate in hemodialysate,which has strong specificity,good stability and high accuracy,and is suitable for the detection of hemodialysate with different formulations.

关 键 词：血液透析液 碳酸氢根 检测方法 返滴定法 

分 类 号：R459.5[医药卫生—治疗学]