金茵利胆口服液指纹图谱及峰归属研究

HPLC Fingerprint and Peak Attribution Research for Jinyin Lidan Oral Liquid

目的:建立金茵利胆口服液的高效液相指纹图谱,提高金茵利胆口服液质量控制水平。方法:采用HPLC法,迪马Ⅱ钻石C18色谱柱(250 mm×4.6 mm,5μm),流动相乙腈-0.1%磷酸梯度洗脱,流速:1.0 ml·min^(-1),检测波长:254 nm。采用"中药色谱指纹图谱相似度评价系统"进行相似度计算,确定金茵利胆口服液指纹图谱研究方法。结果:各批次金茵利胆口服液共获得20个共有峰,超过总面积95%,所得指纹图谱方法学考察结果良好,采用色谱指纹图谱相似度评价软件,对指纹图谱进行相似度计算,其10批样品相似度均大于0.9。结论:运用指纹图谱分析技术,能体现金茵利胆口服液有效成分群的指纹信息,为提高金茵利胆口服液质量控制提供有效方法。

Objective: To establish a method for the fingerprint detection of Jinyin Lidan oral liquid by HPLC in order to acquire more chemical information about the preparation. Methods: HPLC was performed on a Diamonsil Ⅱ diamond C18 column(250 mm×4.6 mm,5 μm) with gradient elution of acetonitrile-0.1% phosphoric acid at a flow rate of 1.0 ml · min-1 and detection wavelength at254 nm. The similarity evaluation system of chromatographic fingerprint of traditional Chinese medicine recommended by State Food and Drug Administration was used to calculate the similarity,and the research method for Jinyin Lidan oral liquid fingerprint was determined. Results: There were 20 common peaks in each batch of Jinyin Lidan oral liquid,which accounted for more than 95% of the total area. The research results of the fingerprint method were good. The similarity of 10 batches of Jinyin Lidan oral liquid was more than0.9. Conclusion: Fingerprint analysis technology can reflect the fingerprint information of the effective components in Jinyin Lidan oral liquid,which provides an effective method for improving the quality control of Jinyin Lidan oral liquid.