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。
Abstract
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
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Key words
sucrose /
quality control /
optical rotation /
HPLC /
ion chromatography /
vaccine
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李晓东 张雅军.
疫苗制品中蔗糖组分质控方法的研究[J]. 中国药学杂志, 2010, 45(3): 218-220
LI Xio-dong;ZHNG Y-jun .
Quality Control Method of Sucrose in Vaccine Product[J]. Chinese Pharmaceutical Journal, 2010, 45(3): 218-220
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参考文献
[1] Ch. P(2005) Vol Ⅲ (中国药典2005年版.三部) [S]. 2005:Appendix 35-36.
[2] MARTENS D A, FRANKENBERGER W T. Determination of saccharides by high performance anion-exchange chromatography with pulsed amperometric detection [J]. Chromatographia, 1990, 29(1-2):7-12.
[3] YU H, MOU S F. Methods of amperometric detection and its application in ion chromatography[J]. Chemistry(化学通报), 2007,70(7):483-488.
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脚注
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