白蛋白制剂中辛酸含量的测定

Determination of the Content of Octanoic Acid in Human Plasma Albumin

在检品中加入定量庚酸作内标,经酸处理,氯仿抽提,溶剂挥发浓缩后,用气相层析法测定。在制作标准曲线时,以不同辛酸量和各自的辛酸与内标庚酸的峰面积比值回归。将检品测得的峰面积比值代入回归方程,即可求得辛酸含量。本法的回收率为96.88±1.19％;对17批制品分别重复测定4次的差异系数在1.21～4.62％之间,平均为2.72％,本法操作相对简便,可作为白蛋白辛酸含量的质控方法。

A method of determining the content of the octanoic acid in human plasma albumin by gas chromatograph (GC) was repoted. The samples added in heptanoic acid as internal standard were previously treated by perchloric acid, extrated by chloroform and concentraed, then detected by GC. A graph was prepared by plotting the ratio of peak area of octanoic acid as abscissa and ordinate, respectively, and a regression equation was obtained from the graph. The content of actanoic acid could be calculated from the ratio of peak area of octanoic acid to heptanoic acid in samples by the regression. The recovery rate in this assay was 96.88±1.19%, and the coefficient of variation in 17 batches of products detected by this method for 4 times averaged 2.72% (1.21~4.62%). The method was relatively simple and convenient to handle and could be used to control the content of octanoid acid in human plasma albumin.