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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×4.6 mm,5μm),以乙腈-0.1%甲酸水为流动相梯度洗脱,柱温40℃,流速1 m L/min,检测波长240 nm,进样量20μL。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,10批糖痹康颗粒制剂的HPLC指纹图谱相似度在0.90以上,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。
OBJECTIVE To establish the HPLC fingerprinting of Bi-bi-kang granule, evaluate its quality scientifically and control its quality effectively to ensure the stability of its production. Methods The chromatographic column (250 mm × 4.6 mm, 5 μm) was run on an RP-18 endcapped column with a mobile phase of acetonitrile-0.1% formic acid at a flow rate of 1 mL / min and a detection wavelength of 240 nm, injection volume 20μL. Using the State Pharmacopoeia Commission “Chinese medicine chromatographic fingerprint similarity evaluation system 2004A version” of 10 batches of biweixang granule formulations for similarity evaluation, and the prescription of 9 herbs for the correlation analysis. Results The HPLC fingerprinting of the baibikang granules was preliminarily established with the baicalin as the reference peak. The similarity of the HPLC fingerprints of the 10 batches of the tablets was more than 0.90, indicating 25 common peaks, of which 18 belonged to the square In the herbs. Conclusion The separation method is good, accurate and simple, which can be used as a reference for the evaluation of the quality of the granules.