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阿莫西林中高分子杂质的测定与质量分析
引用本文:李哲媛, 李玉凤, 范兵, 向金莲. 阿莫西林中高分子杂质的测定与质量分析[J]. 中国现代应用药学, 2006, (4): 326-327.
作者姓名:李哲媛  李玉凤  范兵  向金莲
作者单位:云南省药品检验所,昆明,650011
摘    要:目的比较不同厂家阿莫西林原料、胶囊、混悬剂中高分子杂质的含量。方法采用OhpakSB-802.5HQ(聚合基柱)高效液相凝胶色谱系统进行分离分析。结果21批阿莫西林样品中高分子杂质的测定结果均为1%以下。结论国产与进口阿莫西林中的高分子杂质含量无显著差异。

关 键 词:阿莫西林  高分子杂质  凝胶色谱
文章编号:1007-7693(2006)04-0326-02
收稿时间:2005-03-14
修稿时间:2005-03-14

Studies on the separation and quality of high molecular weight impurities in amoxicillin
LI Zhe-yuan, LI Yu-feng, FAN Bing, XIANG Jin-lian. Studies on the separation and quality of high molecular weight impurities in amoxicillin[J]. Chinese Journal of Modern Applied Pharmacy, 2006, (4): 326-327.
Authors:LI Zhe-yuan  LI Yu-feng  FAN Bing  XIANG Jin-lian
Affiliation:Yunnan Institute for Drug Control ,Kunming 650011, China
Abstract:OBJECTIVE To develop a method for determination the high molecular impurities in amoxieillin to evaluate the quality of amoxieillin and its capsule or suspension. METHODS Determination of high molecular impurities using Ohpak SB-802.5HQ gel filtration chromatography was established. RESULTS 21 batehas of amoxieillin were analyzed. The contents of the high molecular impurities were all less than 1%. CONCLUSION Results of analysis showed there were no significant differents in the contents of impurities between domestic and imported.
Keywords:amoxieillin   high molecular impurities    gel filtration chromatography
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