国产美洛昔康片在健康人体内的药代动力学及相对生物利用度  

Pharmacokinetics and bioavailability of meloxicam in healthy volunteers

作　　者：姚兵[1] 张银娣[1] 沈建平[1] 丁红彬[1] 

机构地区：[1]南京医科大学临床药理研究所,江苏南京210029

出　　处：《徐州医学院学报》2002年第2期108-110,共3页Acta Academiae Medicinae Xuzhou

摘　　要：目的　研究国产美洛昔康片和德国产美洛昔康片 (莫比可片 ,参比制剂 )在 2 0名健康志愿者体内的药代动力学及相对生物利用度。方法　双交叉设计、反相高效液相色谱法测定美洛昔康血药浓度。结果　国产美洛昔康片主要药动学参数分别为 :半衰期 (halftime ,t1/ 2 ,h) :2 4.16± 4.43;峰值浓度 (peakconcentration ,Cmax,mg·L-1) :1.6 37± 0 .2 79;达峰时间 (peaktime ,Tmax,h) :4.9± 1.6 ;0～ 96h曲线下面积 (areaunderthecurve ,AUC0～ 96,mg·h·L-1) :5 5 .80± 14.35 ;0～∞小时曲线下面积 (AUC0～∞ ,mg·h·L-1) :5 9.99± 15 .91。美洛昔康片对参比片的相对生物利用度 (F ,%)为 :10 1.3± 9.0。两者的lnAUC、lnCmax、平均峰保留时间 (meanreservetime ,MRT)经交叉试验下的方差分析和双单侧检验证明无显著性差异 (P >0 .0 5 )。结论　美洛昔康片和莫比可片具有生物等效性。Objective To investigate the pharmacokinetics and bioavailability of meloxicam tablet and Mobic (reference) in 20 healthy male volunteers.?Methods A single dose of 15 mg meloxicam was given according to a randomized two-way cross-over design. A reverse phase HPLC-UV method was used to determine meloxicam concentrations in plasma over 96 h. Results The main pharmacokinetic parameters of test drug were as follows: half time (t 1/2 , h):24.16±4.43;peak concentration (C max , mg·L -1 ):1.637±0.279;peak time (T max , h):4.9±1.6; area under the curve (AUC 0～96 , mg·h·L -1 ):55.80± 14.35; AUC 0～∞ (mg·h·L -1 ):59.99±15.91.There was no significant difference between pharmacokinetic parameters of the two preparations (P>0.05). The relative bioavailability of test drug was (101.3±9.0)%.?Conclusion There was an excellent bioequvalence of domestic meloxicam compared to imported one.

关 键 词：美洛昔康 相对生物利用度 高效液相色谱法 药物动力学 非甾体抗炎药 

分 类 号：R971.1[医药卫生—药品] R969.1[医药卫生—药学]