动力学分光光度法测定增溶性辅料Tween 80的溶血过程

Kinetic spectrophotometric study on hemolytic process of polysorbate 80

Tween 80又名聚山梨酯80,化学名为聚氧乙烯20山梨醇酐单油酸酯,为淡黄色至橙黄色的黏稠液体,是由山梨醇、脂肪酸和环氧乙烷等聚合形成的高分子混合物,在药学领域中常作为液体制剂的增溶性辅料进行应用和研究，收载于2005版中国药典二部。

To establish kinetic assay method for the analysis of hemolysis and to investigate dynamic hemolytic process of polysorbate 80. The UV-VIS spectrum of heme changes when hemoglobin is released continuously during the hemolytic process. Therefore,dynamic hemolytic curve was determined as a new way to characterize the kinetic process of interaction between polysorbate 80 and red blood cells. The effect of polysorbate 80 on blood cells could be perfectly investigated by the hemolytic dynamics. Dynamic hemolytic parameters of polysorbate 80 were calculated according to the hemolytic curves. The constants of hemolytic rate and maximum hemolytic rate of polysorbate 80 had fine linear relationships at the range of 1-20 mg·mL^-1 and 5-20 mg·mL^-1,respectively. In comparison with the present official method such as macroscopic observation and static spectrophotometric methods,kinetic spectrophotometry has the advantages of real time,on-line determination,sensitive,objective,good reproducibility and 2-dimensional information acquired. Therefore,as a biological technique,kinetic spectrophotometry could be applied to evaluate the quality of polysorbate 80 and to screen other solubilizing excipients.