疫苗制品中蔗糖组分质控方法的研究  

Quality Control Method of Sucrose in Vaccine Product

作　　者：李晓东[1] 张雅军[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药学杂志》2010年第3期218-220,共3页Chinese Pharmaceutical Journal

摘　　要：目的研究对比疫苗中蔗糖检验的3种仪器分析方法。方法建立了基于比旋度、高效液相色谱-示差折光检测法和离子色谱-积分脉冲安培检测法对疫苗制品中蔗糖进行质控分析的方法。结果在选定的分析条件下,比旋度、高效液相色谱-示差折光检测法和离子色谱-积分脉冲安培检测法均能准确给出疫苗制品中蔗糖的含量。结论比旋度分析在没有背景干扰的情况下简单易行,高效液相色谱-示差折光检测法和离子色谱-积分脉冲安培检测法则具有更强的专属性及更高的准确度。OBJECTIVE To study three instrumental analysis methods of sucrose in vaccine product. METHODS The quality control methods of sucrose were performed by specific optical rotation, high performance liquid chromatography-refractive index detection （HPLC-RID） and ion chromatography-integrated pulsed amperometric detection（IC-IPAD）. RESULTS Under the selected conditions, specific optical rotation, HPLC-RID and IC-IPAD methods provided accurately the concentration of sucrose in vaccine product. CONCLUSION Specific optical rotation is easy to implement when matrix interferences don＇t influence the assay. However, HPLC- RID and IC-IPAD methods are more specification and accuracy for the identification and quantitative analysis of sucrose in vaccine product.

关 键 词：蔗糖 质量控制 旋光 高效液相色谱 离子色谱 疫苗 

分 类 号：R917[医药卫生—药物分析学]