含糖血液透析液中葡萄糖含量检测方法的探讨  

The Discussion on the Detection of Glucose in Glucose-Containing Hemodialysate Fluid

作　　者：柯军[1] 叶晓燕[1] 张海悦 魏滢 何晓帆[1] 黄麒谕 KE Jun;YE Xiao-yan;ZHANG Hai-yue;WEI Ying;HE Xiao-fan;HUANG Qi-yu(Guang dong Medical Devices Quality Surveillance and Test Institute,NMPA Key Laboratory for Extracorporeal Circulation Devices,Guangzhou Biomedical Blood Purification Materials Research and Development Key Laboratory,Guangdong Guangzhou 510663;Jilin Fusheng Medical Devices CO.,LTD,Jilin Changchun 130607)

机构地区：[1]广东省医疗器械质量监督检验所,国家药品监督管理局体外循环器械重点实验室,广州市生物医用血液净化材料研究与开发重点实验室,广东广州510663 [2]吉林省富生医疗器械有限公司,吉林长春130607

出　　处：《中国医疗器械信息》2020年第23期23-25,共3页China Medical Device Information

基　　金：广东省食品药品监督管理局重点实验室项目:体外循环器械国家重点实验室(项目编号:2018ZDZ04);广州市产学研协同创新重大专项:血液净化吸附产品关键共性技术攻关与产业化研究(项目编号:201604046010);广州开发区科技创新局项目:高性能血液灌流器的临床应用与产业化研究(项目编号:201802010019)。

摘　　要：目的:针对旋光仪检测透析液中葡萄糖含量时遇到的检测结果不稳定问题,探索建立一种更加可靠的检测方法。方法:采用碘量法检测透析液中葡萄糖含量,通过对该方法进行重复性、稳定性及回收率实验,考察了方法的可行性。结果:该方法检测透析液中葡萄糖含量,平均回收率分别为100.45%、100.13%、99.87%,RSD值为0.29%。结论:本方法具有重复性好、准确度高的优点,可用于含葡萄糖透析液的检测和质量控制。Objective:For the instability detection problems of glucose content in dialysate with polarimeter,a more reliable method was explored.Methods:Iodine quantity method is adopted to detect the glucose content of dialysate in the test.The repeatability,stability and recovery experiment by this method were used to investigate the feasibility of the method.Results:The average recovery rate of glucose were 100.45%,100.13%,99.87%,and the RSD was 0.29%.Conclusions:The method has the advantages of good repeatability and high accuracy,and can be used for the quality control and the detection of glucose levels in dialysate.

关 键 词：含糖透析液 葡萄糖 碘量法 

分 类 号：TH776[机械工程—仪器科学与技术]