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目的:考察比较玳玳黄酮自微乳化软胶囊、玳玳黄酮有效部位及普通硬胶囊在SD大鼠体内的药代动力学和口服生物利用度。方法:SD大鼠分别灌胃玳玳黄酮有效部位、玳玳黄酮普通硬胶囊和玳玳黄酮自微乳化软胶囊,选择玳玳黄酮有效部位主要药效成分柚皮苷和新橙皮苷为评价指标,采用UPLC-MS/MS联用色谱法,同时测定大鼠血浆中柚皮苷与新橙皮苷的浓度。用DAS 3.0药动学软件处理血药浓度数据,用SPSS统计软件独立样本t检验对所得的药动学数据进行显著性差异分析。结果:采用非房室模型分析方法,分别给药玳玳黄酮有效部位与普通硬胶囊后,Cmax、AUC(0-∞)无显著性差异(P>0.05),而给药自微乳化软胶囊后,Cmax、AUC(0-∞)显著增加(P<0.05)。结论:与玳玳黄酮有效部位及其普通硬胶囊相比,玳玳黄酮自微乳化软胶囊可以提高玳玳黄酮的口服生物利用度。
OBJECTIVE: To investigate the pharmacokinetics and oral bioavailability of tortoise shellfruit self-microemulsifying soft capsules, effective parts of tortoise shell flavone and ordinary hard capsules in SD rats. Methods: The SD rats were respectively treated with the effective parts of tomabekonis flavonoids, the ordinary hard capsule of tortoise shell and the self-microemulsifying soft capsule of the tortoise shell flavone. The main active components of naringin and neohesperidin were selected as the evaluation Indicators, using UPLC-MS / MS coupled with simultaneous determination of plasma naringin and neohesperidin concentration. The plasma concentration data were processed with DAS 3.0 pharmacokinetics software, and significant differences were analyzed using the SPSS statistical software independent sample t-test. Results: Non-compartment model analysis showed that Cmax and AUC (0-∞) had no significant difference (P> 0.05) after administration of the effective parts of Daitai flavonoids and ordinary hard capsules, respectively, while administration of self-microemulsifying soft capsules After Cmax, AUC (0-∞) increased significantly (P <0.05). Conclusion: Compared with the effective parts of tortoise and flavonoids and their ordinary hard capsules, tortoise shell flavonoids self-microemulsifying soft capsules can improve the oral bioavailability of tortoise shell flavone.