二氟尼柳片剂人体相对生物利用度  

Relative bioavailability of diflunisal tablet

作　　者：郑马庆[1] 胡正国[2] 朱延勤[1] 潘伟娜[1] 严汉英[1] 张银娣[3] 

机构地区：[1]江苏省药物研究所药理室,南京210009 [2]浙江平湖制药厂,平湖314200 [3]南京医科大学药理学教研室,南京210029

出　　处：《中国临床药学杂志》2000年第5期291-293,共3页Chinese Journal of Clinical Pharmacy

摘　　要：目的 :比较二氟尼柳片剂与胶囊剂人体药物动力学和生物利用度。方法 :采用高效液相色谱法测定 10名健康志愿者单次口服 5 0 0 mg片剂或胶囊剂后 ,二氟尼柳在血浆中的药物浓度 ,计算两者的药物动力学参数和相对生物利用度。结果 :二氟尼柳片剂和胶囊剂人体药 -时曲线符合一室开放模型 ,其主要药物动力学参数 T1 / 2 分别为 (10 .46± 1.33)和 (10 .75± 2 .2 1)h;cmax分别为 (30 .76± 3.2 0 )和 (2 9.93± 2 .2 6 ) mg/ L;tmax分别为 (2 .2 2± 0 .31)和 (2 .13± 0 .6 1) h;MRT分别为 (17.33± 1.84)和 (17.48± 2 .88) h;AUC0→ t分别为 (4 34.33± 5 3.2 1)和 (4 2 8.5 5± 6 8.0 0 ) m g· h/ L;二氟尼柳片剂对胶囊剂的相对生物利用度为 (10 2 .2± 8.94) %。两制剂的 AUC、cmax及 ln AUC、lncmax经方差分析和双单侧检验法证明无显著性差异 (P>0 0 5 )。结论AIM: To compare the pharmacokinetics and relative bioavailability of diflunisal tablet and capsule in humans. METHODS: The plasma concentration of diflunisal was assayed by high performance liquid chromatography (HPLC) method after a single dose of 500 mg given to 10 healthy volunteers in an two period crossover study. RESULTS: It was found that the characteristic of diflunisal plasma concentration time curve fitted to one compartment model. The main pharmacokinetic parameters of diflunisal tablet and capsule were as follows: T 1/2 =(10 46±1 33) and (10 75±2 21) h: c max =(30 76±3 20) and (29 93±2 26) mg/L; t max =(2 22±0 31) and (2 13±0 61) h; MRT=(17 33±1 84) and (17 48±2 88) h; AUC 0→t =(434 33±53 31) and (428 55±68 00) mg·h/L, respectively. The relative bioavailability of diflunisal tablet was (102 22±8 94)%, compared with diflunisal capsule. No statistical difference was found in AUC, c max , lnAUC and ln c max between 2 formulations. CONCLUSION: The result of statistical analysis shows that the 2 formulations are bioequivalent.

关 键 词：二氟尼柳 片剂 相对生物利用度 血药浓度 

分 类 号：R96[医药卫生—药理学]