测定聚乙二醇化天花粉蛋白注射液中氰基硼氢化钠残留量的两种方法比较  

Comparison of 2 Methods for the Detection of Residual NaCNBH3 in PEGylated Trichosanthin Injection

作　　者：张立虎[1] 童珊珊[1] 李艳萍[1] 

机构地区：[1]盐城卫生职业技术学院药学院,江苏盐城224006

出　　处：《中国药房》2014年第1期64-66,共3页China Pharmacy

摘　　要：目的：建立测定聚乙二醇化天花粉蛋白（PEG-TCS）注射液中氰基硼氢化钠（NaCNBH3）残留量的方法。方法：分别采用加入考马斯亮蓝蛋白分析试剂的分光光度法（595nm波长）和酶标仪法（570衄波长，每孔反应溶液取量120肛1）进行检测。结果：分光光度法和酶标仪法的NaCNBH。检测浓度线性范围分别为0．05～0．30、0．049-0．78mmol／L（r=0．9995、0．9993），检测限分别为0．0125、0．024mmol／L，平均加样回收率分别为97．5％、98．3％（RSD分别为0．53％、0．68％，n=3）。结论：两种方法均可测定NaCNBH。残留量，但酶标仪法因用样量少、快速、操作简便，更适合样品中NaCNBH3残留量的测定。OBJECTIVE： To establish the method for the detection of residual NaCNBH3 in PEGylated trichosanthin （PEG- TCS） injection. METHODS： Spectrophotometer method （595 nm wavelength） added with coomassie blue protein analysis reagents and enzyme-labeled instrument method （570 nm wavelength, 120 μl reaction solution in each plate） were adopted to determination. RESULTS： In spectrophotometer method, the linear ranges of NaCNBH3 were 0.05-0.30 mmol/L （r=0.999 5）, and the limit of de- tection was 0.012 5 mmol/L with an average recovery of 97.5% （RSD=0.53%, n=3）. In enzyme-labeled instrument method, the linear ranges of NaCNBH3 were 0.049-0.78 mmol/L （r=0.999 3）, and the limit of detection was 0.024 mmol/L with an average re- covery of 98.3% （RSD=0.68%, n=3）. CONCLUSIONS： Both methods can be used to detect NaCNBH3 residues. The enzyme-la- beled instrument method is more quick and simple for the detection of NaCNBH3 in samples.

关 键 词：聚乙二醇化天花粉蛋白注射液 氰基硼氢化钠 残留量检测 分光光度计法 酶标仪法 

分 类 号：R927.2[医药卫生—药学]