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    左乙拉西坦缓释片的制备及其Beagle犬体内药动学研究

    Study on Preparation of Levetiracetam Sodium Extended-release Tablet and It's Pharmacokinetics in Beagle Dogs

      摘要
    • 摘要: 目的 制备左乙拉西坦缓释片，进行体外释放特性以及Beagle犬体内药动学研究。方法 按照筛选处方制备左乙拉西坦缓释片，以市售左乙拉西坦缓释片（Keppra-XR）为参比制剂，采用相似因子（f2）法进行体外释放行为相似度评价；并将自制左乙拉西坦缓释片与市售普通片进行Beagle犬体内药动学参数比较。结果 自制左乙拉西坦缓释片与市售左乙拉西坦缓释片体外释放行为相似。市售左乙拉西坦普通片和自制左乙拉西坦缓释片的药动学参数Tmax分别为（1.75±0.50）和（5.50±1.00）h，Cmax分别为（30.33±2.00）和（17.29±3.56）mg·L-1，AUC0-t分别为（186.88±8.83）和（202.50±34.20）mg·L-1·h。结论 自制的左乙拉西坦缓释片具有缓释效果。

       

      Abstract: OBJECTIVE To prepare the Levetiracetam extended-release tablet and investigate its pharmacokinetics in Beagle dogs and in vitro release. METHODS Prearation of Levetiracetam extended-release tablet according to optimized prescription, choosed sell products(Keppra-XR) as reference products, evaluation of in vitro release behavior similarity by the similar factor(f2). The pharmacokinetic parameters were compared between the self-made extended-release tablet and the sell tablet. RESULTS The self-made extended-release tablet was similar to the reference products in vitro release, Tmax of reference products and self-made extended-release tablet were (1.75±0.50) and (5.50±1.00) h, Cmax were (30.33±2.00) and (17.29±3.56) mg·L-1, AUC0-t were (186.88±8.83) and (202.50±34.20) mg·L-1·h. CONCLUSION The self-made Levetiracetam extended-release tablet exhibits the sustained release characteristics in vitro.

       

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