皮肤病血毒片的HPLC指纹图谱研究及3个成分的含量测定  

Study on the HPLC fingerprint and determination of 3 components in Pifubingxuedu Tablets

作　　者：史志辉 肖会敏[2] 何悦[2] 刘洋[3] 刘海月 杨旭[2] 王四旺[2] 

机构地区：[1]陕西君碧莎制药有限公司,咸阳712000 [2]第四军医大学药学院新药研发中心,西安710032 [3]陕西中医药大学,咸阳712046

出　　处：《西北药学杂志》2017年第4期436-440,共5页Northwest Pharmaceutical Journal

基　　金：陕西省科技统筹创新工程计划项目(编号:2016KTZDSF010303)

摘　　要：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。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（250mm×4.6mm,5μm）column.The mobile phase was acetonitrile-5mL·L^-1 phosphoric acid solution in a gradient elution mode.The flow rate was 0.8mL·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 4and 0.208 7mg·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.

关 键 词：绿原酸 小檗碱 甘草酸 皮肤病血毒片 高效液相色谱法 指纹图谱 

分 类 号：R917[医药卫生—药物分析学]