护肝新药GSY-1胶囊的HPLC特征性指纹图谱研究

Study on HPLC fingerprint of fermented liquorices preparations GSY-1 capsules

目的:对护肝新药GSY-1胶囊的高效液相色谱(HPLC)特征性指纹图谱进行研究,为建立该新药的质量评价体系提供依据。方法:色谱柱为Agela Technologies Venusil MP C18(250 mm×4.6 mm,5μm),流动相为乙腈-1%冰醋酸溶液(梯度洗脱),检测波长为254 nm,流速为1.0 ml·min-1,柱温为25℃,记录GSY-1胶囊的HPLC指纹图谱。结果:研究结果提示该药有13个共有峰,多数峰可以达到较好分离;通过"中药色谱指纹图谱相似度评价系统(2004A版)"分析计算,得出10批GSY-1胶囊指纹图谱相似度均在0.978以上。结论:采用HPLC特征性指纹图谱作为发酵中药复方制剂的质量控制具有良好的精密度、稳定性和重复性,可克服复方制剂采用单一指标成分作为质量控制的局限性。

Objective：To establish the HPLC fingerprints of GSY-1 capsules in order to provide basis for the quality evaluation.Methods：The separation was performed on Agela Technologies Venusil MP C18（250 mm×4.6 mm,5 μm） column with a mobile phase consisting of acetonitrile-0.1% acetic acid（gradient elution） at flow rate of 1.0 ml·min-1.Detection wavelength was set at 254 nm and column temperature was 25 ℃.The HPLC fingerprints of GSY-1 capsules were recorded.Results：There were 13 common peaks in HPLC fingerprint of GSY-1 capsules and the similarities were proved to be higher than 0.978 which were calculated with the help of the Similarity Calculation Soft of Fingerprint Chromatography of Traditional Chinese Medicine（2004A）.Conclusion：This method is accurate,stable and reproducible for basis of quality evaluation and fingerprint of GSY-1 capsules.