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目的 以Mobiflex片为参比药物 ,研究替诺昔康片的人体药代动力学和相对生物利用度 ,以判断两种制剂是否具有生物等效性。方法 2 4名健康志愿者随机分组交叉自身对照给药 ,每次服药后 2 4 0h内多点采血 ,HPLC法测定血清中药物浓度。结果 两制剂的血药浓度经时变化基本一致 ,替诺昔康片和Mobiflex片的主要药代动力学参数分别为 :T1/2Ke(6 9 6 8± 12 5 6 )h ,(6 8 75± 13 39)h ;Cmax(2 95±0 5 0 )mg·L-1,(2 82± 0 4 8)mg·L-1;AUC0～t(2 0 9 70±32 4 3)mg·L-1·h-1,(2 0 0 6 5± 18 5 7)mg·L-1·h-1;AUC0～∞(2 2 8 4 5± 36 0 7)mg·L-1 h-1,(2 18 11± 2 1 34)mg·L-1·h-1;Tmax(2 75± 1 0 7)h ,(2 75± 1 11)h ,经配对t检验差异均无显著性。替诺昔康片相对生物利用度为10 5 0 6 %± 16 6 1% (99 2 5 %～ 110 87% )。结论 替诺昔康片与Mobiflex片具有生物等效性
OBJECTIVE To study the pharmacokinetics and relative bioavailability of tenoxicam tablets using Mobiflex as a reference drug to determine whether the two preparations are bioequivalent. Methods Twenty-four healthy volunteers were randomly assigned to cross-over self-administration. Blood samples were taken at 240 h after each drug administration, and serum concentrations were determined by HPLC. Results The plasma concentrations of the two preparations were basically the same over time. The main pharmacokinetic parameters of tenoxicam tablets and Mobiflex tablets were T1 / 2Ke (6 9 6 ± 12 5 6) h, (6 8 75 ± 13 39) h; Cmax (2 95 ± 0 5 0) mg · L -1, (2 82 ± 0 48) mg · L -1; AUC 0 ~ t (2 0 9 70 ± 32 4 3) mg · L-1 · h-1, (20 06 ± 18 57) mg · L-1 · h-1; AUC0 ~ ∞ (2 284 ± 36 0 7) mg · L -1 h- 1, (2 18 11 ± 2 1 34) mg · L-1 · h-1; Tmax (2 75 ± 1 0 7) h and (2 75 ± 1 11) h respectively, no significant difference was found by paired t-test . The relative bioavailability of tenoxicam tablets was 105.06% ± 16.6% (99.25% ~ 110.87%). Conclusion Tenoxicam tablets are bioequivalent to Mobiflex tablets