尼美舒利_____尼美舒利;生物利用度;

尼美舒利胶囊人体相对生物利用度研究

http://www.100md.com 《广东药学院学报》 2000年第4期

尼美舒利,,尼美舒利;生物利用度;,HPLC;,药物动力学,1材料与方法,2实验结果,3讨论,参考文献

     摘要采用双交叉试验设计，用HPLCUV法测定不同时相的血药浓度，进行药代动力学分析，结果表明:10名健康志愿者分别一次口服受试制剂及参比片剂200 mg后所得的药时曲线均符合一室开放模型。尼美舒利胶囊与片剂的主要药动学参数分别为:T1/2K(h)，4.25±0.58和4.67±0.45;Cmax(mg·L-1)，9.28±2.20和8.92±2.48；Tmax(h)，2.88±0.51和2.79±0.55；MRT(h)，9.30±0.92和9.50±0.60；AUC0→24(mg·h·L-1)，87.02±26.88和86.98±25.33；这些参数经方差分析法证明无显著性差异(P<0.05)。尼美舒利胶囊对片剂的相对生物利用度(F%)为：100.54±11.01。两者的AUC、Cmax、Tmax及lnAUC、lnCmax、lnTmax经交叉试验下的方差分析法证明无显著性差异，经双单侧检验证明尼美舒利胶囊与片剂具有生物等效性。

    关键词尼美舒利;生物利用度; HPLC; 药物动力学

    SHEN Jianping1,ZHU Yanqin2,ZHENG Maqing2,PAN Weina2 LI Mengqiu1，YAO bing1，ZHANG Yindi1，YAN Hanying2

    1.The Institute of Clinical Pharmacology Nanjing Medical University，Nanjing 210029; 2.Jiangsu Institute of Materia Medica

    Abstract Objective: to compare the pharmacokinetics and bioavailability of nimesulide capsules with nimesulide tablets .Method: a single 200 mg oral dose of nimesulide capsule or tablet was given to 10 healthy male volunteers in a randomized double crossover study. Plasma levels of nimesulide were detected by HPLCUV method. Results: The pharmacokinetic parameters of nimesulide capsules and tablets were as follewed :T1/2K(h):4.25±0.58 and 4.67±0.45 ;Cmax(mg·L-1)：9.28±2.20 and 8.92±2.48；Tmax(h):2.88±0.51 and 2.79±0.55；MRT(h):9.30±0.92 and 9.50±0.60；AUC0→24 (mg·h·L-1): 87.02±26.88 and 8698±25.33 respectively. The relative bioavailability of nimesulide capsule was 100.54±11.01 %. There were no significant differences between pharmacokinetic parameters for the two formulations of nimesulide(P>005).The nimesulide capsules showed bioequivalence compared with the tablets . ......

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