头孢泊肟酯片在男性健康志愿者体内生物等效性研究

Study on Bioequivalence of Cefpodxime Proxetil Tablets in Male Healthy Volunteer

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 study the bioequivalence of the tested and reference cefpodxime proxetil tablets in 20 male healthy volunteers. Method: According to the crossover design, each volunteer was orally given 200 mg of cefpodxime proxetil tablets. The serum concentrations were determined by HPLC. Pharmacokinetic parameters were obtained by using DAS program. Separation was achieved on the Agilent ZORBAX×SB-C18 column, the mobile phase consisted of water: acetonitrile: triethylamine ( 100: 14: 1 ,V/V/V) . The UV-detecting wavelength was 240 nm ,acetanilide as internal standard. Result: After a single oral dose of 200 mg, t1/2ke were (4. 74±0.46) h and (4.86±0.37) h,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,respectively. The related bioavailability was (102. 15±23.4)%. Conclusion: The result showed that two tablets are bioequivalent.