| 引用本文: | 徐兵勇,潘迎锋,平丽.左乙拉西坦缓释片的制备及其Beagle犬体内药动学研究[J].中国现代应用药学,2017,34(9):1266-1271. |
| XU Bingyong,PAN Yingfeng,PING Li.Study on Preparation of Levetiracetam Sodium Extended-release Tablet and It's Pharmacokinetics in Beagle Dogs[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(9):1266-1271. |
|
| 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。 |
| 关键词: 左乙拉西坦 缓释片 药动学 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.09.011 |
| 分类号:R943;R969.1 |
| 基金项目: |
|
| Study on Preparation of Levetiracetam Sodium Extended-release Tablet and It's Pharmacokinetics in Beagle Dogs |
|
XU Bingyong1,2, PAN Yingfeng1, PING Li3
|
|
1.Zhejiang Center for Drug and Cosmetics Evaluation, Hangzhou 310012, China;2.Chiatai Qingchunbao Pharmaceutical Co., Ltd., Hangzhou 310012, China;3.Center for Drug Safety Evaluation, Zhejiang University, Hangzhou 310058, China
|
| 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. |
| Key words: Levetiracetam extended-release tablet pharmacokinetics |
