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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 whether there are differences in the pharmacokinetics and bioavailability between the two nabumetone tablets.Methods: Twelve male nabumetone tablets were given nabumetone at the crossover point and were analyzed by high performance liquid chromatography The concentration of 6-methoxy-2-naphthaleneacetic acid, the active metabolite of TDS in plasma, within 120h after administration was determined.RESULTS: The main pharmacokinetic parameters were as follows: Tp = 6.41 ± 3.05h, t1 / 2β = 21.77 ± 3.62h, c max = 23.73 ± 4.10mg / L, AUC = 1.10.67 ± 205.54mg · h / L; the control tablets Tp = 10.63 ± 5.10h, t1 / 2β = 21.53 ± 4.77 h and c max = 18.77 ± 5.39 mg / L and AUC = 954.10 ± 263.66 mg · h / L, respectively.Conclusion: The test piece absorbed faster (P = 0.012) and higher peak concentration P = 0.029). The mean relative bioavailability was 112.36%. There was no significant difference (P = 0.52) between AUC and matched T test.