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目的针对玳玳总黄酮有效部位多组分特性,基于HPLC特征图谱研究玳玳黄酮自微乳化软胶囊制备过程中的药效成分转移率。方法采用HPLC特征图谱法,色谱柱为Lichrocart C18(250 mm×4.0 mm,5μm);流动相为甲醇-0.1%的磷酸水溶液(梯度洗脱);流速1.0 mL·min-1;检测波长284 nm;柱温30℃。结果玳玳黄酮自微乳化软胶囊制备工艺过程中8个共有峰的转移率为80.55%~95.93%,其中主要特征成分柚皮苷和新橙皮苷迁移率均>95%,各药效成分群整体迁移相似度>0.999。结论玳玳黄酮自微乳化软胶囊制备工艺能够比较完整的保留玳玳总黄酮提取物的整体药效部位成分群。
OBJECTIVE To study the multi-component characteristics of the effective fractions of Tohto Daiki Flavonoids, the efficiencies of the active ingredients in Toadaira flavonoids self-microemulsifying capsules were studied based on HPLC characterization. Methods The HPLC chromatogram was performed on a Lichrocart C18 column (250 mm × 4.0 mm, 5 μm). The mobile phase was methanol-0.1% phosphoric acid solution (gradient elution). The flow rate was 1.0 mL · min-1. The detection wavelength was 284 nm ; Column temperature 30 ℃. Results The transfer rates of eight common peaks during the preparation of the softgels of Daiibei flavones were 80.55% ~ 95.93%. The main characteristic components of naringin and neohesperidin were all higher than 95% in mobility. Each of the active ingredients Group overall migration similarity> 0.999. Conclusion The preparation technology of the tortoise shell flavone self-microemulsifying soft capsule can completely retain the whole medicinal part component group of the tortoise shell total flavone extract.