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研究国内研制的头孢呋辛酯片剂与参比制剂 (西力欣 )在健康人体内的生物利用度与生物等效性。方法 :用高效液相 紫外法测定血浆中的头孢呋辛的浓度 ,以头孢呋辛酯的市售片剂西力欣为对照 ,通过 2 2名受试者的单剂量交叉给药 ,对研制的头孢呋辛酯片剂进行相对人体生物利用度及生物等效性考察。结果 :研制的头孢呋辛酯片剂和西力欣片的AUC[0 ∞ ] 分别为 (12 .7± 4.5 )和 (13.2± 4.8)mg·L-1·h ;Cmax分别为 (3.5± 1.2 )和(3 .9± 1.7)mg·L-1;Tmax分别为 (1.9± 0 .9)和 (2 .2± 1.0 )h ;MRT分别为 (3 .9± 1.3)和 (3 .8± 1.5 )h ;T1/ 2 分别为(2 .3± 1.8)和 (1.9± 1.7)h。说明研制的头孢呋辛酯片和西力欣片的各种主要的药物动力学参数接近。研制的头孢呋辛酯片的相对生物利用度 (F)达到 95 .42 %。研制的头孢呋辛酯片剂和参比制剂西力欣片的AUC[0 ∞ ] 之间差异无显著性 (P >0 .0 5 ) ,90 %的置信区间在 80 %～ 12 5 %范围内 ;Cmax的 90 %置信区间也在 70 %～ 143 %的范围内。结论 :研制的头孢呋辛酯片和市售进口的西力欣片在健康人体内达生物等效。
To study the bioavailability and bioequivalence of cefuroxime axetil tablets and reference preparation (Celecoxib) in healthy volunteers in China. Methods: The concentration of cefuroxime in plasma was determined by high performance liquid ultraviolet (UV) spectrophotometry. The cefuroxime axetil was administered as a commercial tablet of cefuroxime axetil in a single dose of 22 subjects. Of cefuroxime axetil tablet relative human bioavailability and bioequivalence study. Results: The AUC [0 ∞] of cefuroxime axetil tablets and xili tablets were (12.7 ± 4.5) and (13.2 ± 4.8) mg · L-1 · h, respectively; the Cmax were (1.9 ± 0.9) and (2.2 ± 1.0) h respectively; MRT was (3.9 ± 1.3) and (3 .9 ± 1.3) mg · L- 8 ± 1.5) h; T1 / 2 were (2. 3 ± 1.8) and (1.9 ± 1.7) h, respectively. The results showed that the main pharmacokinetic parameters of Cefuroxime axetil tablets and Xilixin tablets were similar. The relative bioavailability (F) of cefuroxime axetil tablets developed was 95.42%. There was no significant difference (P> 0.05) between the developed cefuroxime axetil tablet and the reference drug xilixin tablet in the range of 80% -12 5% ; The 90% confidence interval for Cmax is also in the range of 70% to 143%. CONCLUSIONS: Cefuroxime axetil tablets developed and commercially available Xilixin tablets are bioequivalent in healthy humans.