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药学学报  2013 

快速筛查中药注射液中有害物质5-羟甲基糠醛的lc-ms/ms方法及其质量评价研究

, PP. 1705-1709

Keywords: 中药注射液,5-羟甲基糠醛,lc-ms/ms,质量评价

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Abstract:

快速筛查常用中药注射液中有害物质5-羟甲基糠醛,并以其含量为指标进行质量评价。利用lc-ms/ms分析方法,对56批市售的23种常用中药注射液和葡萄糖注射液中的5-羟甲基糠醛进行定量分析,在52批中检出5-羟甲基糠醛。在所检的样品中5-羟甲基糠醛的最低含量为0.0038μg·ml-1,最高含量为1420μg·ml-1;不同种类、不同厂家、同一厂家不同批次生产的中药注射液中5-羟甲基糠醛的含量差异很大。结果表明,以5-羟甲基糠醛含量为指标,市售的中药注射液质量良莠不齐;需要对中药注射液中5-羟甲基糠醛的安全性予以关注,并制定统一的限量标准,以提高中药注射液的用药安全。

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