决明子萘并吡喃酮类对照提取物研究及其在决明子药材质量控制中的应用

Study on naphthopyrone reference extract and application on assay of Semen Cassiae

建立以决明子萘并吡喃酮类对照提取物为对照的决明子药材质量控制方法,探讨对照提取物在中药质量控制中应用的可行性。采用色谱分离技术制备决明子萘并吡喃酮类对照提取物,以决明子苷B_2、红镰霉素-6-O-β-D-龙胆二糖苷及决明子苷C对照品为对照,对决明子萘并吡喃酮类对照提取物进行标定。以已知含量的对照提取物为对照,建立决明子药材HPLC含量测定方法,并与以对照品为对照的含量测定结果进行比较,结果表明,2种含量测定方法无显著差异。该结果为决明子萘并吡喃酮类对照提取物在决明子药材质量控制中的应用提供科学依据,为中药对照提取物替代单一对照品进行中药质量控制奠定基础,为中药质量控制提供新的研究思路和模式。

A quality control method of Semen Cassiae was established by using naphthopyrone reference extract（ NRE）. Meanwhile,the feasibility about NRE replacing single component reference in quality control of traditional Chinese medicine was explored. After NRE of Semen Cassiae being prepared by chromatographic separation technology,we determined the three main components,cassiaside B_2,rubrofusarin-6-O-β-D-gentiobioside and cassiaside C. In the meantime,an HPLC analytical method,based on the NRE as standard substance,was developed to determinate the contents of three main components in Semen Cassiae. T-test was used for comparison of the determination results of the two methods（ single chemical component and NRE as reference substances,respectively）,and the T-test result demonstrated that there was no significant difference between the two methods. The results developed scientific basis for the application of NRE of Semen Cassia in the quality control,which could be applied for the quality control of traditional Chinese medicine using reference extract substituting single chemical reference,and provide a new research model for the quality control of Chinese medicine.