山豆根药材及配方颗粒的HPLC指纹图谱研究

Study on HPLC Fingerprint of Sophorae tonkinensis Radix et Rhizoma Medicinal Materials and Formula Granules

摘要: 目的：建立山豆根配方颗粒HPLC指纹图谱分析方法，并比较山豆根药材及配方颗粒的差异性，为山豆根药材及配方颗粒的质量控制提供参照。方法：采用高效液相色谱法，色谱柱为Diasonsil C18 (4.6 mm × 250 mm, 5 μm)，流动相为乙腈-0.1%磷酸水溶液(梯度洗脱)，柱温为25℃，检测波长为210 nm。结果：山豆根药材相似度在0.903~0.979之间，有31个共有峰，10批山豆根配方颗粒相似度在0.995~1.000之间，有23个共有峰，山豆根药材与配方颗粒之间的相似度在0.853~0.958之间，山豆根药材与配方颗粒有19个共有峰。结论：该方法稳定、重复性较好、分离度较好及专属性较强，可以有效地对山豆根药材及配方颗粒进行质量控制，从而探索山豆根药材及配方颗粒的差异性，为临床使用山豆根配方颗粒提供参考。

Abstract: Objective: To establish an HPLC fingerprint analysis method for Sophorae tonkinensis Radix et Rhizoma formula granules, and compare the differences between Sophorae tonkinensis Radix et Rhizoma medicinal herbs and formula granules, providing reference for the quality control of Sophorae tonkinensis Radix et Rhizoma medicinal herbs and formula granules. Method: Using high- performance liquid chromatography (HPLC) for detection, the chromatographic column is Diasonsil C18 (4.6 mm × 250 mm, 5 μm). The mobile phase was acetonitrile 0.1% phosphoric acid aqueous solution (gradient elution), with a column temperature of 25˚C and a detection wavelength of 210 nm. Result: The similarity of Sophorae tonkinensis Radix et Rhizoma medicinal herbs ranges from 0.903 to 0.979, with 31 common peaks. The similarity of 10 batches of Sophorae tonkinensis Radix et Rhizoma formula particles ranges from 0.995 to 1.000, with 23 common peaks. The similarity between Sophorae tonkinensis Radix et Rhizoma medicinal herb and formula granules ranges from 0.853 to 0.958, and there are 19 common peaks between Sophorae tonkinensis Radix et Rhizoma medicinal herb and formula granules. Conclusion: This method is stable, reproducible, with good separation and strong specificity, and can effectively control the quality of Sophorae tonkinensis Radix et Rhizoma formula granules, thereby exploring the differences between Sophorae tonkinensis Radix et Rhizoma medicinal materials and formula granules, and providing reference for clinical use of Sophorae tonkinensis Radix et Rhizoma formula granules.