红曲药材中洛伐他汀含量和指纹图谱质量评价.PDF

红曲药材中洛伐他汀含量和指纹图谱质量评价.PDF

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1226 红曲药材中洛伐他汀含量及指纹图谱的质量评价 * * 王明娟,刘静,康帅,麻思宇,程显隆,魏锋,戴忠 ,马双成 (中国食品药品检 定研究院,北京 100050) 摘要 目的: 方法: 初步调查红曲药材的质量现状。 从市场上随机抽取5份红曲药材,依据《中国药典》 2015版一部收载方法考察其指纹图谱以及其主要功效成分洛伐他汀的含量。结果:抽取到的5份红曲药材 的指纹图谱与《中国药典》收载的对照图谱以及彼此之间均有显著性差异,均未检出洛伐他汀(最低检 出限约为1 ng),显微鉴别难以发现红曲发酵菌紫色红曲霉的典型特征。结论:目前流通市场上的红曲 药材质量一致性较差,亟需规范提高。 关键词: 红曲;质量调查;指纹图谱;含量测定;洛伐他汀 R917 A 1002-7777(2018)09-1226-06 中图分类号: 文献标识码: 文章编号: doi:10.16153/j.1002-7777.2018.09.012 Quality Evaluation of the Content of Lovastatin and Fingerprint Chromatogram of Fermentum Rubrum * * Wang Mingjuan, Liu Jing, Kang Shuai, Ma Siyu, Cheng Xianlong, Wei Feng, Dai Zhong , Ma Shuangcheng (National Institutes for Food and Drug Control, Beijing 100050, China) Abstract Objective: To investigate the quality status of Fermentum Rubrum. Methods: Five Fermentum Rubrum samples were randomly collected from the market. The fingerprint chromatograms and the contents of the main functional component, lovastatin, of the five Fermentum Rubrum samples were analyzed according to the method described in Chinese Pharmacopeia (2015 version). Results: There were significant differences between the fingerprint chromatograms of the five Fermentum Rubrum samples and the reference one adopted in Chinese Pharmacopeia. There were also significant differences among the fingerprint chromatograms of the five Fermentum Rubrum samples. No lovastatin was detected (the minimum detection limit was about 1 ng). Typical characteristics of Monascus purpuresu were difficult to be found by microscopic identification in these samples. Conclusion: The current quality comparability of Fermentum Rubrum in the circulation market is relatively

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