胸腺肽高分子量物质检测方法的优化  

Optimization of the methods for detecting high molecular weight component in thymosin

作　　者：陈妍珂[1] 王亚鹏 王孝功 郭欢迎 刘海静 

机构地区：[1]西安交通大学医学院,陕西西安710061 [2]西安迪赛生物药业有限责任公司,陕西西安710016 [3]陕西食品药品检定所,陕西西安710061

出　　处：《中国生化药物杂志》2012年第5期622-624,共3页Chinese Journal of Biochemical Pharmaceutics

基　　金：国家科技支撑计划"药品注射剂检测技术体系研究"(编号2008BAI55B04)

摘　　要：目的优化现行胸腺肽质量标准中控制高分子量(Mw)物质的检测方法,解决该方法存在的对照品Mw大小与洗脱时间矛盾的问题。方法采用高效液相凝胶过滤色谱法(HPGFC),改变流动相的组成,建立高Mw物质的分析方法,并进行方法学验证。结果确定三氟乙酸-乙腈-水(0.05∶45∶55)作为流动相的HPGFC分析方法,在该洗脱条件下,对照品的洗脱顺序符合Mw变化的规律,经过方法学验证,改进后的方法更适于检测高Mw物质的含量。结论优化后的高Mw物质检测方法可用于胸腺肽制剂的质量控制,并为其他生化制剂高Mw蛋白检测提供了方法学参考。Purpose To optimize the detection methods for high molecular weight component in the current quality control of thymosin and to solve the contradiction between the molecular weight of standard preparation and elution time. Methods High performance gel filtration chromatography （HPGFC） was used to analyze the high molecular weight component. The mobile phase was altered to find out the most suitable one. Also the methodology verification was done. Results The analysis of HPGFC was carried outwith the mobile phase of trifluoacetic acid-acetonitrile-water（0.05：45：55）. Under the condition, the elu- tion order of control article coincided with the variation of molecular weight. After verification of accuracy, repetitiveness and stability,it was found that the improved method was more suitable for detecting the a- mount of high molecular weight component. Coneluslon The optimized detecting method of high molecu- lar weight component can be used in the quality control of thymosin preparation and it provides a method- ological reference for the detection of other biochemical high molecular weight proteins.

关 键 词：胸腺肽 高分子量物质 高效液相凝胶过滤色谱 

分 类 号：R927[医药卫生—药学]