用旋光度法测定静脉注射用人免疫球蛋白中麦芽糖含量

Measuring the contents of maltose in IVIG by the method of specific rotation

用旋光度测定法测定静脉注射用人免疫球蛋白 (IVIG)中麦芽糖含量 ,简便、快速 ,准确 ,重复性好 ,麦芽糖浓度与旋光度成正比 ,用该方法制备标准曲线具有很好的相关性 ,相关系数r(n =10 ) ±s为 0 .99996± 0 .0 0 0 0 3。测定两批IVIG ,分别重复测定 9次 ,麦芽糖含量分别为 9.85± 0 .0 82和 9.5 5± 0 .0 85变异系数分别为 0 .6 0 % ,0 .6 9% ,该法的内标回收率 % (n =9) ±s分别为 10 0 .4%± 0 .82和 98.8%± 0 .85 。

It is very simple,rapid,accurate and repeatable to measure the content of maltose in IVIG by the method of specific rotation,and the concentration of maltose is proportional to the specific rotation. The standard curve by this method has very good relativity,relative coefficient r(n=10)±s is 0.99996+0.00003.Two batchs of IVIG were measured for 9 times respectively, the mean content of maltose are 9.85±0.082,9.55±0.085,variable coefficients are 0.60% and 0.69%,and the recovery rate of inner references% (n=9)±s are 100.4%±0.82 and 98.8%±0.85 respectively.So We suggest that this method can be used as the routine test to determine the contents of maltose in IVIG.