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牛磺酸有关物质检查的方法研究及质量考察 被引量:2

Study on Examination of Related Substance in Taurine and Quality Inspection of Domestic Products
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摘要 目的用薄层色谱法对牛磺酸有关物质检查方法进行研究,并考察国内产品质量。方法以牛磺酸-丙氨酸混合溶液为系统适用性溶液,使用硅胶G薄层板,筛选比较3种展开体系、4种显色方式,采用条带式点样,点样量5μL。结果以水-无水乙醇-正丁醇-冰醋酸(150:150:100:1)为展开剂,可使系统适用性溶液斑点分离良好,而以茚三酮的丙酮溶液(1→50)为显色剂,检视效果最佳。国内两种不同工艺生产的9批牛磺酸原料的纯度很高,几乎无杂质检出。结论所用方法简便、灵敏,能有效检测牛磺酸的有关物质,国内产品质量优异。 Objective To establish a TLC examination method for the related substances in taurine and to investigate the quality of domestic taurine.Methods The taurine-alanine mixture solution was selected as the test solution for system suitability.Using the silica gel G thin-layer plate,three different of developing solvent systems and four coloration methods were screened and compared with the banding type sampling and the sample size of 5 μL test solution.Results The spots of system suitability test solution were well separated with TLC by water-absolute alcohol-butanol-glacial acetic acid(150 ∶150 ∶100 ∶1)as developer and with the acetone solution of ninhydrin(1→50) as the coloring reagent,the viewing effects was optimal.Nine batches of domestic taurine raw material manufactured by two different pharmaceutical technologies had very higher purity and almost no impurities were detected by current method.Conclusion The established method is simple and sensitive,which can effectively detect the related substances in taurine.The domestic taurine products are good in quality.
出处 《中国药业》 CAS 2011年第4期35-36,共2页 China Pharmaceuticals
关键词 牛磺酸 有关物质 薄层色谱法 质量考察 taurine related substance TLC quality inspection
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