血液透析器中PVP溶出的定量检测方法  

Quantitative analysis method of PVP elution speciallized for hemodialyzer

作　　者：牟倡骏 李井龙 于亚楠 曲佳伟 丛慧 MU Changjun;LI Jinglong;YU Ya'nan;QU Jiawei;CONG Hui(Shandong WEGO Blood Purification Products Co.,Ltd.,Weihai 264200,China)

机构地区：[1]山东威高血液净化制品股份有限公司,山东威海264200

出　　处：《中国测试》2023年第11期91-95,183,共6页China Measurement & Test

基　　金：国家科技支撑计划(2014BAI11B00)。

摘　　要：血液透析器中PVP的溶出量作为透析器安全性评估的重要指标,其常规测试方法是Müller法(聚维酮-碘络合物光度法),研究表明Müller法受PVP分子量分布的影响较大。该文提出一种紫外检测法,该方法是通过194nm波长下直接测试标准溶液和供试液的吸光度,根据浓度-吸光度线性回归方程计算PVP的溶出量,方法操作简单且不受PVP分子量分布的影响。对比FX80和Elisio-15H的PVP溶出量可知,紫外检测法测试值近似相同,分别为4.33μg/mL和4.26μg/mL;然而Müller法测试结果偏低且相差较大,分别为2.53μg/mL和3.17μg/mL。可见紫外检测法比Müller法更适用于血液透析器制备的供试液中PVP溶出量的检测。As an important index to evaluate safety of hemodialyzers,the amount of polyvinylpyrrolidone(PVP)eluted is generally measured by Müller method,known as Povidone-iodine complex spectrophotometry.Studies have shown that Müller method is greatly affected by the molecular weight distribution of PVP.In the present paper,a visible ultraviolet(UV)detection method has been proposed,which directly tests the absorbance of standard solution and test solution at 194nm wavelength,and calculates the eluted amount of PVP according to the linear regression equation of concentration and absorbance.The UV detection method is simple to operate and not affected by the molecular weight distribution of PVP.By comparing the PVP elution of FX80 and Elisio-15H,test results of UV detection method were approximately the same,4.33μg/mL and 4.26μg/mL respectively;however,results of Müller method were lower and the difference was large,2.53μg/mL and 3.17μg/mL respectively.The present study proves that visible UV detection method is more suitable than Müller method for detecting PVP elution in the test solution prepared by hemodialyzers.

关 键 词：PVP 血液透析器 紫外检测法 Müller法 

分 类 号：R114[医药卫生—卫生毒理学] TB9[医药卫生—公共卫生与预防医学]