洛伐他汀胶囊药动学与相对生物利用度  

Pharmacokinetics and relative bioavailability of lovastatin capsule

作　　者：蒋学华[1,2,3] 赵语[1,2,3] 何林 何毅[1,2,3] 周天杰 

机构地区：[1]华西医科大学药学院 [2]成都市中心血站 [3]华西医科大学附属第四医院药剂科

出　　处：《中国药学杂志》1998年第11期669-672,共4页Chinese Pharmaceutical Journal

摘　　要：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，ｔｍａｘ分别为：（２．５±０．４）ｈ与（２．５±０．３）ｈ，ｃｍａｘ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，ｃｍａｘ，ｔｍａｘ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）％。OBJECTIVE:To study the pharmacokinetics and relative bioavailability of lovastatin capsule.METHODS:100 mg 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.

关 键 词：洛伐他汀 胶囊 生物利用度 药物动力学 

分 类 号：R972.6[医药卫生—药品] R944.5[医药卫生—药学]