人免疫球蛋白中甘氨酸含量控制的研究

人免疫球蛋白中甘氨酸含量控制的研究

林海,杨景麟,田洪,潘震宇,肖炳燚,肖菁,姚亮元

湖南省食品药品检验研究院;湖南省食品药品检验研究院;湖南省食品药品检验研究院;湖南省食品药品检验研究院;湖南省食品药品检验研究院;湖南省食品药品检验研究院;湖南千金湘江药业股份有限公司

收稿日期:2013-08-22 修回日期:2013-09-02 出版日期:2013-08-25 发布日期:2013-08-25
基金资助:
湖南省卫生厅科研基金课题，立项编号：B2011-115

Research on the content control of glycine in human immunoglobulin

Hunan Institute for Food and Drug Control;Hunan Institute for Food and Drug Control;Hunan Institute for Food and Drug Control;Hunan Institute for Food and Drug Control;Hunan Institute for Food and Drug Control;Hunan Institute for Food and Drug Control

Received:2013-08-22 Revised:2013-09-02 Online:2013-08-25 Published:2013-08-25

摘要/Abstract

摘要： 【】目的人免疫球蛋白中甘氨酸含量的检测和控制方法。方法本次临床研究使用特定设备对人免疫球蛋白中的甘氨酸含量进行了检测和有效控制,并在338mm波长条件下,通过外标法对甘氨酸水平进行了计算。结果人免疫球蛋白中甘氨酸衍生化范围在0.05至0.15g/L之间,甘氨酸回收率在96%至101%之间,其直线相关系数为0.9996至1.0000,不同操作者检测结果对比无明显差异。结论通过RF-HPLC方法对人免疫球蛋白中甘氨酸含量进行检测和控制,具有较高的准确性和稳定性,因而应用价值较高。

Abstract: 【】Objective: To establish the method for the content determination and control of glycine in human immunoglobulin. Methods: This clinical study detected and controlled the glycine content in human immunoglobulin effectively by special equipment. The glycine levels were calculated (wavelength = 338mm, external standard). Results: The derivatization range of glycine in human immunoglobulin is from 0.05 to 0.15g/L,the recovery rate of the glycine is between 96% and 101%,and the linear correlation coefficient is from 0.9996 to 1.0000. There is no significance comparative difference between different operators in the test results. Conclusion: The RF-HPLC method is of higher accuracy and stability for the content determination and control of glycine in human immunoglobulin, thus the method has higher application value.

林海,杨景麟,田洪,潘震宇,肖炳燚,肖菁,姚亮元. 人免疫球蛋白中甘氨酸含量控制的研究[J]. .