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目的研究吴茱萸碱水包油型复合物纳米乳[EPBCN(O/W)]的体内外评价,即体外释放特征和大鼠药动学研究。方法考察EPBCN在pH 1.2盐酸和pH 6.8 PBS溶液中的释放特征及大鼠口服生物利用度,并对吴茱萸碱(evodiamine,ED)和EPBCN进行生物等效性评价。结果 EPBCN的最大累积释放率约为ED的2.61倍,EPBCN的口服生物利用度为ED的7.35倍,ED与EPBCN的血药浓度-时间曲线下面积(AUC_(0-72 h))和药峰浓度(ρ_(max))的90%置信区间超出标准范围。结论 EPBCN(O/W)能明显提高ED的体外释放和大鼠口服生物利用度,且二者生物不等效性。
Objective To study the in vitro and in vivo evaluation of evodiamine oil-in-water nanocomposite nanoemulsion (EPBCN (O / W)], in vitro release characteristics and pharmacokinetics in rats. Methods The release characteristics and oral bioavailability of EPBCN in pH 1.2 hydrochloric acid and pH 6.8 PBS solution were investigated. The bioequivalence of evodiamine (ED) and EPBCN was evaluated. Results The maximum cumulative release rate of EPBCN was about 2.61 folds of that of ED. The oral bioavailability of EPBCN was 7.35 times that of ED. The area under the plasma concentration - time curve (AUC 0-72 h) and peak The 90% confidence interval for concentration (ρ_ (max)) is outside the standard range. Conclusions EPBCN (O / W) can obviously improve the in vitro release of ED and oral bioavailability in rats, and the bioavailability of both is not the same.