盐酸齐拉西酮固体分散体胶囊在比格犬体内药代动力学研究

发布时间：2018-05-14 08:10

本文选题：盐酸齐拉西酮 + 固体分散体　；参考：《中国医院药学杂志》2015年18期

【摘要】：目的:考察盐酸齐拉西酮固体分散体胶囊在比格犬体内的药动学过程,评价其生物等效性及吸收是否受食物影响。方法:通过建立盐酸齐拉西酮在比格犬血浆样品的RP-HPLC测定方法,以市售盐酸齐拉西酮胶囊(Zeldox)为参比制剂,对市售胶囊和自研胶囊进行空腹和饱腹下比格犬体内药动学研究。结果:建立了盐酸齐拉西酮比格犬血样测定方法,该方法处理简单,快速,准确。市售Zeldox胶囊和自研胶囊在饱腹Cmax为(243±82)和(124±62)ng·L-1,空腹下为(255±74)和(261±64)ng·L-1,AUC(0-24)分别为(3 798±374),(2 004±254),(3 943±336)和(3 912±331)ng·L-1·h。结论:自研盐酸齐拉西酮固体分散体胶囊空腹和饱腹下吸收均良好,吸收不受食物影响。经生物等效性评价分析可知,自研盐酸齐拉西酮固体分散体胶囊空腹和饱腹下与市售胶囊饱腹下等效。
[Abstract]:Aim: to investigate the pharmacokinetic process of ziprasidone hydrochloride solid dispersible capsule in Beagle dogs and evaluate its bioequivalence and food absorption. Methods: a RP-HPLC method was established for the determination of ziprasidone hydrochloride in the plasma samples of beagle dogs. Zeldox hydrochloride capsule was used as a reference preparation. The pharmacokinetics of Zeldox capsules and Zeldox capsules were studied in vivo. Results: a simple, rapid and accurate method for the determination of ziprasidone hydrochloride was established. The commercial Zeldox capsules and self-made capsules were 3 798 卤374 64)ng L ~ (-1) and 3 943 卤336 ~ (3 943 卤336) h respectively for satiety Cmax (n = 2 943 卤336h) and C _ (124 卤62)ng ~ L ~ (-1), and F _ (261 卤64)ng L ~ (-1) for AUC ~ (0-24) for 3 912 卤331)ng 路L ~ (-1) h, respectively. Conclusion: the self-made ziprasidone hydrochloride solid dispersible capsule has good absorption under stomach and full stomach, and its absorption is not affected by food. The bioequivalence analysis shows that the self-made ziprasidone hydrochloride solid dispersible capsule is equivalent to the market capsule under full stomach and empty stomach.
【作者单位】：南京工业大学生物与制药工程学院;南京工业大学药学院;
【分类号】：R965

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