洛伐他汀胶囊药动学与相对生物利用度

 目的：研究po洛伐他汀胶囊与美降之片后，洛伐他汀在血浆中的药动学与相对生物利用度。方法：采用反相高效液相色谱法测定10名志愿受试者单剂量po100mg洛伐他汀胶囊与美降之片后，洛伐他汀血药浓度变化情况，计算药动学参数与相对生物利用度，并以配对t检验与双单侧t检验进行统计分析。结果：两制剂的AUC分别是：(334.8±40.9)ng·h·ml^-1与(343.2±54.2)ng·h·ml^-1,t_max分别为:(2.5±0.4)h与(2.5±0.3)h,c_max分别是:(45.6±4.8)ng·ml^-1与(43.3±5.9)ng·ml^-1。配对t检验与双单侧t检验结果表明：AUC，c_max，t_max均无显著性差异(P>0.05)。结论：洛伐他汀胶囊与美降之片为生物等效制剂；洛伐他汀胶囊的相对生物利用度为(98.45±10.18)%。

Pharmacokinetics and relative bioavailability of lovastatin capsule

OBJECTIVE:To study the pharmacokinetics and relative bioavailability of lovastatin capsule.METHODS:100mg single oral dose of lovastatin capsule and Mevacor tablet were given to 10 volunteers in an open randomized cross-over test.Lovastatin concentrations in serum were assayed by RP-HPLC method.RESULTS:Lovastatin the AUC of the capsule and Mevacor tablet were (334.8±40.9) ng·h·ml^-1 and( 343.2±54.2 )ng·h·ml^-1 ,t_max(2.5±0.4)h and (2.5 ±0.3)h,c_max(45.6±4.8)ng·ml^-1 and (43.3±5.9)ng·ml ^-1 respectively.The relative bioavailability of lovastatin capsule was (98.45±10.18)% compared to Mevacor tablet.CONCLUSION:The result of statistical analysis showed that the two formations were bioequivalent.