摘要
目的建立护肝片HPLC指纹图谱,并对其中6种主要药效成分同时定量分析。方法采用CAPCELL PAK C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.4%磷酸水溶液,梯度洗脱;运用中药色谱指纹图谱相似度评价系统(2004 A版)对10批护肝片的HPLC指纹图谱进行相似度评价。结果通过10批样品的测定,建立护肝片HPLC指纹图谱,相似度均在0.90以上;同时对护肝片中绿原酸、表告依春、柴胡皂苷b2、五味子醇甲、五味子甲素、五味子乙素6种主要药效成分进行了含量测定。结论所建立的方法灵敏度高、专属性强,HPLC指纹图谱结合多成分含量测定能全面反应其内在质量,可用于护肝片的整体质量控制及评价。
Objective To establish an HPLC fingerprint of Hugan tablets, and to simultaneously determine 6 medicinal components in Hugan tablets. Methods Separation was performed on CAPCELL PAK C18 analytical column （250 mm×4.6 mm,5μm） with the mobile phase of acetonitrile-0.4% phosphoric acid by gradient elution. The similarity of l0 batches of Hugan tablets was evaluated by Similarity Evaluation System for Chromatographic Fingerprint of Chinese Materia Medica 2004A. Results Fingerprints of 10 batches of Hugan tablets were established and the similarities were all above 0.9. Meanwhile, the contents of 6 major medicinal components in Hugan tablets, namely chlorogenic acid, epigoitrin, saikosaponin b2, schisandrin, deoxyschisandrin, and schisandrin B were determined. Conclusion The method is highly sensitive and specific. The combination of HPLC fingerprint and multi-component determination reflects its inherent quality in an all- round way, and it can be used for the quality control and evaluation of Hugan tablets.
出处
《中南药学》
CAS
2018年第1期31-34,共4页
Central South Pharmacy
基金
国家中药标准化项目(No.ZYBZH-C-HLJ-15)
