皮肤病血毒片的HPLC指纹图谱研究及3个成分的含量测定

目的建立皮肤病血毒片的高效液相色谱(HPLC)指纹图谱,测定绿原酸、小檗碱和甘草酸的含量。方法采用HPLC法。色谱条件:Kromasil C18柱(250 mm×4.6 mm,5μm);流动相为乙腈-5 mL·L-1磷酸水溶液,梯度洗脱;流速为0.8mL·min-1;检测波长为254nm;柱温为25℃。结果通过中药色谱指纹图谱相似度评价系统(2004A)确定了皮肤病血毒片的HPLC指纹图谱共有模式,标定了42个共有峰,相似度为0.958~0.992;并测得10批制剂中绿原酸、小檗碱和甘草酸的含量分别为0.299 7,0.272 4和0.208 7mg·片-1,RSD值分别为2.32%,2.65%和1.95%。结论皮肤病血毒片的HPLC指纹图谱及其中绿原酸、小檗碱和甘草酸的含量检测方法简便、准确、重复性好,可用于该制剂的质量控制。

Study on the HPLC fingerprint and determination of 3 components in Pifubing-xuedu Tablets

Objective To establish an HPLC fingerprint method for the quality control of Pifubingxuedu Tablets,and to determine the contents of chlorogenic acid,berberine and glycyrrhizic acid.Methods HPLC was performed on a Kromasil C18(250 mm×4.6 mm,5 μm) column.The mobile phase was acetonitrile-5 mL·L-1 phosphoric acid solution in a gradient elution mode.The flow rate was 0.8 mL·min-1,the detection wavelength was 254 nm, and the column temperature was set at 25 ℃.Results Under the above chromatographic conditions,the characteristic fingerprint peak of Pifubingxuedu Tablets was composed of 42 chromatographic peaks, and the similarity was 0.958-0.992 through the chromatographic fingerprint similarity evaluation system (2004A) analysis.And the average contents of chlorogenic acid,berberine, and glycyrrhizic acid were 0.299 7,0.272 4 and 0.208 7 mg·tablet-1,respectively,and their RSDs were 2.32%,2.65% and 1.95%,respectively,in 10 batches of Pifubingxuedu Tablets.Conclusion The method is simple,accurate and have a good repeatability.The study provides a foundation for the quality evaluation and quality control standards of Pifubingxuedu Tablets.