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目的:建立化痔片的质量标准。方法:采用TLC对处方中槐米、枳壳、茜草、三七进行鉴别;用HPLC测定槐米中芦丁的含量。Fuji silysia C18柱(4.6 mm×150 mm,5μm),流动相乙腈-0.2%磷酸(17∶83),流速1.0 mL.min-1,检测波长256nm。结果:在TLC色谱中检出槐米特征成分芦丁、枳壳特征成分橙皮苷和柚皮苷、茜草特征成分大叶茜草素、三七成分人参皂苷Rg1,斑点清晰,分离度好;芦丁在0.198～0.990μg与峰面积呈良好的线性关系,r=1.000,平均回收率98.5%,RSD0.85%。结论:方法可行、重复性好,适用于该制剂的质量控制。
Objective: To establish the quality standard of Hemorrhoid Tablet. Methods: The prescriptions of Sophora japonica, Fructus Aurantii, Rubia cordifolia and Panax notoginseng were identified by TLC. The content of rutin in Sophora japonica L. was determined by HPLC. Fuji Silysia C18 column (4.6 mm × 150 mm, 5 μm), mobile phase acetonitrile-0.2% phosphoric acid (17:83), flow rate 1.0 mL · min-1 and detection wavelength of 256 nm. Results: The components of S. japonicum were identified as rutin, hesperidin and naringin in the fractions of Fructus Aurantii by TLC, and Rg1 was the characteristic component of Rubia cordifolia and the ginsenoside Rg1 of Panax notoginseng. The spots were clear and the resolution was good. The linear range of 0.198 ~ 0.990μg was linear with the peak area, with the average recovery of 98.5% and the RSD of 0.85%. Conclusion: The method is feasible and reproducible, which is suitable for the quality control of the preparation.