目的建立评价茵栀黄注射液质量的指纹图谱分析方法。方法高效液相色谱条件Kromasil 100-5C₁₈色谱柱(4.6 mm×25 cm,5μm);甲醇-0.05%磷酸溶液为流动相进行二元梯度洗脱;流速1.0 mL·min^-1;检测波长为238nm;柱温30℃。结果建立了茵栀黄注射液中绿原酸类、栀子苷类、黄芩苷类成分的指纹图谱,并建立了共有峰模式、全谱相似度和去黄芩苷相似度模式3种指纹图谱分析评价方法。结论建立的茵栀黄注射液指纹图谱的重现性、稳定性好,可以有效地控制茵栀黄注射液的质量。

OBJECTIVE To establish a method for determining the fingerprints of Yinzhihuang Injection by HPLC.METHODS The separation was performed on a Kromasil 100-5C₁₈ column(4.6 mm×25 cm,5μm) with linear gradient elution.The flow rate was 1.0mL·min^-1 and the mobile phase consisted of methanol and 0.05%phosphoric acid solution.The detection wavelength was at 238nm and the temperature was at 30℃.RESULTS Three kinds of components in Yinzhihuang Injection were identified as chlorogenic acid,geniposide and Baicalin by fingerprints.Three evaluate methods for fingerprints of Yinzhihuang Injection were established,including the common peaks model,similarity degree model of whole fingerprints and similarity degree model deducted the peak of baicalin.CONCLUSION The HPLC fingerprints of Yinzhihuang Injection is stable and reproducible,and it can control the quality of Yinzhihuang Injection effectively.