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目的:评价头孢泊肟酯片剂在20名男性健康志愿者体内的生物等效性。方法:20名健康受试者随机、双交叉、单剂量口服国产头孢泊肟酯片(试验片)和进口头孢泊肟酯片(参比片)200 mg。药物血清浓度采用HPLC法测量;药动学参数采用DAS软件处理。色谱柱为Agilent ZORBAX×SB-C18,流动相为水:乙腈:三乙胺(100:14:1,V/V/V),紫外检测波长为240 nm,乙酰苯胺为内标。结果:2种制剂t1/2ke分别为(4.74±0.46)h和(4.86±0.37)h,tmax分别为(2.90±0.20)h和(2.95±0.22)h,AUC0-24分别为(17.148±6.594)mg·h·L-1和(17.517±4.919)mg·h·L-1。试验药和参比药相比,相时生物利用度为102.15%±23.4%。结论:国产与进口头孢泊肟酯片剂具有生物等效性。
OBJECTIVE: To evaluate the bioequivalence of cefpodoxime proxetilis tablets in 20 male healthy volunteers. METHODS: Twenty healthy subjects were randomized, double-crossover, single-dose oral domestic cefpodoxime proxetil tablets (test tablets) and 200 mg cefpodoxime proxetil tablets (reference tablets). The drug serum concentration was measured by HPLC method. The pharmacokinetic parameters were analyzed by DAS software. The column was Agilent ZORBAX × SB-C18 with a mobile phase of water: acetonitrile: triethylamine (100: 14: 1, V / V / V). The detection wavelength was 240 nm. Acetanilide was the internal standard. Results: The t1 / 2ke of the two preparations were (4.74 ± 0.46) h and (4.86 ± 0.37) h respectively, the tmax were (2.90 ± 0.20) h and (2.95 ± 0.22) h, AUC0-24 were (17.148 ± 6.594 ) mg · h · L-1 and (17.517 ± 4.919) mg · h · L-1. Compared with the reference drug, the phase-to-phase bioavailability was 102.15% ± 23.4%. Conclusion: Domestic and imported cefpodoxime proxetil tablets have bioequivalence.