美洛昔康片的人体药物动力学及生物利用度

Pharmacokinetics and relative bioavailability of meloxicam tablet in Chinese healthy volunteers

目的 :研究美洛昔康片的药物动力学及相对生物利用度。方法 :采用随机交叉试验设计 ,2 0名男性健康志愿者单剂量口服试验品与参比品 15mg ,以HPLC法测定血药浓度。结果 :试验品和参比品的AUC0→t分别为 (5 2 85± 12 18) ,(5 7 10±15 5 5 )h·μg·mL-1;AUC0→∞ 分别为 (5 7 90± 14 0 3) ,(6 3 98± 19 94)h·μg·mL-1;cmax分别为 (1 493± 0 338) ,(1 6 82± 0 399) μg·mL-1;tmax分别为 (5 6 5± 3 17) ,(4 6 0± 1 82 )h ;T1/ 2 分别为 (2 6 2 9± 4 37) ,(2 8 0 3± 6 75 )h。 2种美洛昔康片的主要动力学参数 :AUC0→t,AUC0→∞ ,cmax,tmax和T1/ 2 经方差分析显示均无统计学差异 (P >0 0 5 )。AUC经双单侧t检验证明 ,试验品与参比品生物等效 ,试验品的相对生物利用度为 (94 46± 14 6 0 ) % (n =2 0 )。结论

AIM: To study the pharmacokinetics and relative bioavailability of meloxicam tablets in Chinese healthy volunteers. METHODS: Twenty male healthy volunteers received 15 mg meloxicam tablet orally in a random crossover design. Drug concentrations in plasma were determined by high performance liquid chromatography. RESULTS: The pharmacokinetic parameters of tested and reference tablets were as follows AUC 0→t: (52.85±12.18) h·μg·mL -1 vs (57.10±15.55) h·μg·mL -1, AUC 0→∞: (57.90±14.03) h·μg·mL -1 vs (63.98±19.94) h·μg·mL -1, c max: (1.493±0.338) μg·mL -1 vs (1.682±0.399) μg·mL -1, t max: (5.65±3.17) h vs (4.60±1.82) h, T 1/2: (26.29±4.37) h vs (28.03±6.75) h, respectively. There were no significant differences in the pharmacokinetic parameters between the 2 tablets (P>0.05). CONCLUSION: The relative bioavailability of meloxicam tablets is (94.46±14.60)%. The results show that 2 preparations have bioequivalence.