瑞力芬片剂口服人体药代动力学及生物利用度研究  

The pharmacokinetics and bioavailability of nabumetone tablets in healthy volunteers

作　　者：秦永平[1] 梁德荣[1] 邹远高[1] 徐楠[1] 梁茂植[1] 苗佳[1] 黄英[1] 张辉明[1] 余勤[1] 

机构地区：[1]华西医科大学附属第一医院临床药理研究所,成都610041

出　　处：《中国现代应用药学》1998年第5期24-26,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的:检测2种萘丁美酮片剂的药代动力学及生物利用度是否有差异.方法:12例男性健康受试者交叉口服2种萘丁美酮片剂,用高效液相色谱法规定服药后120h内的血浆中蔡丁美酮活性代谢物6-甲氧基-2-萘乙酸浓度.结果:测得主要药代动力学参数为;试验片剂Tp=6.41±3.05h,t1/2β=21.77±3.62h,c_(max)=23.73±4.10mg/L,AUC=1.10.67±205.54(mg·h)/L;对照片剂Tp=10.63±5.10h,t1/2β=21.53±4.77h,c_(max)=18.77±5.39mg/L,AUC= 954.10±263.66(mg·h)/L.结论:试验片与对照片相比吸收较快(P=0.012),峰浓度较高(P=0.029),平均相对生物利用度为112.36%,AUC经配对T检验,无显著性差异(P=0.52).OBJECTIVE:To determine the difference of pharmacokinetics and bioavailability between two nabumetone tabletes. METHODS: Two nabumetone tabletes from different factories were adiministrated crossing over in 12 healthy male volunteers.A reversed phase high performance liquid chromatography was used to determine the main metabolite 6 -methoxy- 2 - naphthylacetic acid in human plasma. RESULTS: The main pharmacokinetic parmeters of sample tablets were Tp =6.41±3.05h,t1/2β = 21.77±3.62h,cmax =23.73±4. 10mg/L,AUC = 1.10.67±205.54(mg h)/L,and those of the spiked sample tablets were Tp = 10.63±5.10h, t1/2β= 21.53±4.77h, cmax = 18.77±5.39mg/L,AUC = 954.10± 263.66(mg· h)/L. CONCLUSION: There is no significant difference of AUC between two nabumetone tablets(P = 0.52). Sample tablets Tp is shorter(P = 0.012) than the spiked sample tablets,and the Cmax, is higher(P= 0.029).

关 键 词：萘丁美酮 生物利用度 药代动力学 瑞力芬 片剂 

分 类 号：R971.1[医药卫生—药品]