文档介绍：糖痹康颗粒HPLC指纹图谱研究
摘要:目的建立糖痹康颗粒HPLC指纹图谱,科学评价并有效控制其质量,确保其生产的稳定性。方法采用德国默克RP-18 endcapped色谱柱(250 mm× mm,5 ?m),以乙腈-%甲酸水为流动相梯度洗脱,柱温40 ℃,流速1 mL/min,检测波长240 nm,进样量20 ?L。采用国家药典委员会《中药色谱指纹图谱相似度评价系统2004A版》对10批糖痹康颗粒制剂进行相似度评价,并对处方中的9味药进行相关性分析。结果以汉黄芩苷为参照峰,初步建立糖痹康颗粒HPLC指纹图谱,,标示出25个共有色谱峰,其中18个归属到方中各药材。结论该方法分离效果好、准确、简单,可为糖痹康颗粒质量评价提供参考。
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关键词:糖痹康颗粒;指纹图谱;相似度
DOI:.1005-
中图分类号: 文献标识码:A 文章编号:1005-5304(2017)06-0075-04
Abstract: Objective To establish the HPLC fingerprints of Tangbikang Granules; To scientifically evaluate and effectively control the quality of Tangbikang Granules; To ensure its production stability. Methods HPLC was performed on the column of Germany Merck RP-18 endcapped (250 mm × mm, 5 ?m) with mobile phase of acetonitrile-% formic acid water; column temperature was 40 ℃; flow rate was mL/min; detection wavelength was 240 nm; volume injection was 20 ?L. Fingerprint Similarity Evaluation Software (edition 2004A) of Chinese mission was used to evaluate the similarity of the 10 batches of Tangbikang Granules, and to analyze the correlations of 9 ingredients in Tangbikang Granules. Results Wogonoside was used as the reference peak, and mon mode for the HPLC fingerprints was set up. The simila