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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。
Objective To prepare levetiracetam sustained-release tablets for in vitro release characteristics and pharmacokinetics in Beagle dogs. Methods According to the screening prescription, the preparation of levetiracetam sustained - release tablets was prepared. The similarity factor (f2) method was used to evaluate the similarity of release behavior of marketed levetiracetam tablets (Keppra - XR) The pharmacokinetic parameters of Beverlyian dogs in vivo were compared with those of self-made levocetirizine sustained-release tablets and commercial tablets. Results The self-made sustained release of levetiracetam was similar to the sustained release of levetiracetam sustained-release tablets in vitro. The pharmacokinetic parameters Tmax of the commercially available levetiracetam ordinary tablets and the self-made levetiracetam sustained release tablets were (1.75 ± 0.50) and (5.50 ± 1.00) h, respectively, and the Cmax values were (30.33 ± 2.00) and 17.29 ± 3.56) mg · L-1 and AUC0-t were (186.88 ± 8.83) and (202.50 ± 34.20) mg · L -1 · h, respectively. Conclusion The self-made levetiracetam sustained-release tablets have a sustained-release effect.