玳玳黄酮自微乳化软胶囊制备过程药效成分转移率考察

Investigation of Transfer Rates of Active Compounds in the Preparation Process of Daidai Flavonoids SMEDDS Soft Capsule

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 transfer rates of active compounds in preparation process of Daidai flavonoids SMEDDS soft capsule upon HPLC characteristic fingerprint considering the property of multiple components in total flavonoids active part of Daidai. METHODS HPLC characteristic fingerprint was adopted with chromatographic column Lichrocart C18（250 mm × 4.0 mm, 5 ktm）. Mobile phase was methanol-water with 0.1% phosphoric acid（gradient elution）. The flow rate was 1.0 mL＇min-1 and the detection wavelength was set at 284 nm. The column temperature was controlled at 30 ~C. RESULTS The transfer rates of eight common peaks were between 80.55% and 95.93% in the preparation process of Daidai flavonoids SMEDDS soft capsule. The transfer rates of main characteristic compounds naringin and neohesperidin were 〉95%. And the similarity of holistic transfer rate of each active couponents was 〉0.999. CONCLUTION The preparation technology of Daidai flavonoids SMEDDS soft capsule can reserve the main active compouds in Daidai total flavonoids extract relative completively.