扎莱普隆口腔速溶片的制备及其犬体内生物利用度

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     张 萌 ¹，陈大为¹，马 莉²

    (1. 沈阳药科大学 药学院，辽宁 沈阳 110016；2. 北京生物医药研究所，北京 100091)

    摘要：目的 制备扎莱普隆口腔速溶片，对其体内的药物动力学加以考察并测定该药与分散片之间相对生物利用度。方法 采用冷冻干燥工艺制备口腔速溶片，用液相色谱法测定6只比格犬口服扎莱普隆口腔速溶片和分散片后不同时间血清中扎莱普隆的质量浓度，计算主要药动学参数。结果 经测定扎莱普隆口腔速溶片崩解迅速，5 min 内溶出达80 %，扎莱普隆口腔速溶片和分散片的t_max分别为(0.92±0.20)和(1.70±0.27) h，ρ_max分别为(2.00±0.44)和(1.05±0.22) mg•L^-1，AUC_0-∞分别为(13.42±1.24)和(9.66±1.38)µg•h•L^-1，相对生物利用度为(141.5±26.4)%。结论 冷冻干燥工艺制备的口腔速溶片质量稳定，显著提高了扎莱普隆的生物利用度。

    关键词：药剂学；扎莱普隆；口腔速溶片；冷冻干燥工艺；相对生物利用度

    中图分类号：R943 文献标识码：A

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    Preparation of zaleplon fast dissolving tablets and bioavailability in Beagles

    ZHANG Meng¹, CHEN Da-wei¹, MA Li²

    (1.School of Pharmacy, Shenyang Pharmaceutical University , Shenyang 110016,China; 2.Beijing Institute of Biomedicine, Beijing 100091, China)

    Abstract：Objective To prepare zaleplon fast dissolving tablets, and investigate the pharmacokinetic properties of the tablets and the relative bioavailability compared with zaleplon dispersible tablets. Method Zaleplon fast dissolving tablets were prepared by freeze-drying technology. HPLC method was carried out to determined the concentration of zaleplon in beagle dogs serum. Non-compartment method was used to calculate the main pharmacokinetic parameters after an oral dose 30 mg of zaleplon fast dissolving tablets and dispersible tablets to beagle dogs ......

    http://www.100md.com/html/DirDu/2007/01/19/34/67/61.htm

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