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木糖醇注射液有关物质的薄层色谱研究
引用本文:苏小兰,梁懿.木糖醇注射液有关物质的薄层色谱研究[J].亚太传统医药,2012,8(10):34-35.
作者姓名:苏小兰  梁懿
作者单位:南宁百会药业集团有限公司,广西南宁,530005
摘    要:目的:建立木糖醇注射液中有关物质的薄层鉴别方法。方法:采用薄层色谱法对木糖醇注射液中的有关物质进行定性鉴别。结果:缺木糖醇的阴性对照样品无干扰;最小检测限为2μg;高温、酸破坏和碱破坏条件下稳定,在氧化条件下不稳定,易发生降解,重现性良好。结论:该方法专属性强,能将破坏性试验中的降解产物与主斑点分离,可用于木糖醇注射液有关物质的控制。

关 键 词:木糖醇注射液  薄层色谱法  薄层鉴别

Study on the TLC Method of Related Substance in Xylitol Injection
Su Xiaolan , Liang Yi.Study on the TLC Method of Related Substance in Xylitol Injection[J].Asia-Pacific Traditional Medicine,2012,8(10):34-35.
Authors:Su Xiaolan  Liang Yi
Institution:(Guangxi Nanning Bestway Pharmaceutical Co. Ltd. , Nanning 530005 ,China)
Abstract:Objective:To establish TLC Method for Xylitol injection. Methods:Qualitative identification was adopted in the TLC method of related substance in the Xylitol injection. Results:No interference was detected in negative control sample; detection limit is 2.0μg, the method is stable in high temperature and alkali destroyed conditions, unstable and easy to degrade under Oxidation cir- cumstance, repeatability is good respectively. Conclusion: The method is specific and able to separate the Destructive testing degra- dation with the main spot, can be used as the control method for related substance in xylitol injection.
Keywords:Xylitol Injection  TCL  Related Substance
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