离子色谱法测定肝素钠中草酸根的含量Determination of Oxalic Ion in Heparin Sodium by Ion-chromatography
邓锋,严全鸿
DENG Feng,YAN Quan-hong(Guangdong Provincial Institute for Drug Control
摘要(Abstract)：
目的加强肝素钠的质量控制,建立草酸根检测方法。方法采用离子色谱法对肝素钠中草酸根离子进行测定,并进行方法学验证。结果线性相关系数r=0.9998,加样回收率为95.2%～99.7%,检测40批肝素钠原料发现部分草酸根离子含量较高。结论本方法操作简单,结果准确,灵敏度高,可对肝素钠进行更进一步的质量控制。
Objective To establish a method to determine oxalic ion in heparin sodium,and to improve its quality control.Methods The oxalic ion in heparin sodium was determined by ion-chromatography.Results The linear coefficient correlation was 0.9998,and the recovery rate was 95.2%~99.7%.A total of 40 batches of heparin sodium were tested.The content of oxalic ion in some of those batches was relatively high.Conclusion The method is simple and accurate.
关键词(KeyWords)：
肝素钠;离子色谱;草酸根
heparin sodium;ion-chromatography;oxalic ion
基金项目(Foundation):
作者(Author):
邓锋,严全鸿
DENG Feng,YAN Quan-hong(Guangdong Provincial Institute for Drug Control
参考文献(References)：
- 1 Guerrini M,Beccati D,Shriver Z,et al.Oversulfated chondroitinsulfate is a contaminant in heparin associated with adverse clinicalevents.Nat Biotechnol,2008,26(6):669-675.
- 2国家药典委员会.中华人民共和国药典.第2部.北京:化学工业出版社,2005.附录172-173.
- 3 DeBorba BM,Rohrer JS,Bhattacharyya L.Development andvalidation of an assay for citric acid/citrate and phosphate inpharmaceutlcal dosage forms using ion chromatography withsuppressed conductivity detection.J Pharm Biomed Anal,2004,36(3):517-524.
- 4朱岩.离子色谱原理及其应用.浙江:浙江大学出版社,2002.72-75.