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目的:观察自微乳化给药系统(SMEDDS)对提高银杏酮酯(GBE50)口服吸收效果的影响。方法:将12只SD大鼠随机分为2组各6只,观察组将经自微乳化给药系统处理得到的银杏酮酯口服自微乳灌入大鼠胃中,对照组应用市售杏灵颗粒剂进行灌胃,比较2组药物代谢动力学参数,以此评价2组的口服吸收效果。另以槲皮素、异鼠李素、山奈素对照品3种样品的回收率以检验高效液相色谱仪的精密度。结果:3种对照品进行5次试验,所得回收率比较无统计学意义(P>0.05)。观察组消除半衰期(T1/2)、血药达峰时间(Tmax)均显著低于对照组,血药峰浓度(Cmax)、0~25 h药时曲线下面积(AUC0-25)、0~∞h药时曲线下面积(AUC0-∞)等参数则显著高于对照组(P<0.05)。结论:与市售杏灵颗粒剂比较,SMEDDS可显著提高GBE50的生物利用度,强化口服吸收效果,值得推广应用。
Objective: To observe the effect of self-microemulsifying drug delivery system (SMEDDS) on enhancing the oral absorption of GBE50. Methods: Twelve SD rats were randomly divided into two groups and six rats in each group. The observation group was infused with Ginkgo biloba ester oral self-microemulsion treated with self-microemulsifying drug delivery system. The control group was treated with commercial apricot Ling granules for gavage, compared two groups of pharmacokinetic parameters, in order to evaluate the oral absorption of two groups. The other with quercetin, isorhamnetin, kaempferol reference standard three kinds of sample recovery rate to test the precision of the high performance liquid chromatography. Results: The three reference products were tested 5 times, the recovery rate was not statistically significant (P> 0.05). The elimination half-life (T1 / 2) and peak plasma drug time (Tmax) of the observation group were significantly lower than those of the control group, the peak plasma concentration (Cmax), the area under the curve of the drug 0-55 h (AUC0-25) ∞h drug under the curve area (AUC0-∞) and other parameters were significantly higher than the control group (P <0.05). Conclusion: Compared with the commercially available Xing Ling granules, SMEDDS can significantly improve the bioavailability of GBE50 and strengthen the oral absorption effect, which is worth popularizing and applying.