盐酸二甲双胍肠溶片的人体相对生物利用度

Relative bioavailability of metformin hydrochloride enteric-coated tablets in human

目的 :研究盐酸二甲双胍肠溶片在健康男性志愿者体内的相对生物利用度。方法 :2 0名健康志愿者交叉口服盐酸二甲双胍肠溶片和盐酸二甲双胍肠溶胶囊 ,采用HPLC法测定人血清中盐酸二甲双胍的浓度 ,使用NDST程序对各药动学参数进行方差分析和双单侧t检验。结果 :口服 10 0 0mg盐酸二甲双胍肠溶片和盐酸二甲双胍肠溶胶囊的cmax分别为 :(2 .6 1±0 .85 ) ,(2 .4 1± 0 .84 )mg L-1;tmax分别为 :(3.13± 0 .78) ,(3.4 8± 0 .95 )h ;T1/2 分别为 :(3.80± 0 .99) ,(3.2 9± 0 .5 4 )h ;AUC0→ 16分别为 :(13.95± 3.97) ,(12 .76± 4 .0 2 )mg·h·L-1;AUC0→∞ 分别为 :(14 .78± 3.97) ,(13.4 2± 4 .18)mg·h·L-1。统计学处理结果 ,两剂型的药动学参数间均无显著性差异 ,受试制剂的相对生物利用度为 (113.8± 2 5 9) %。结论

AIM: To study the relative bioavailability of metformin enteric-coated tablets in healthy male volunteers. METHODS: Twenty healthy male volunteers administered a dose of 1 000 mg metformin enteric-coated tablets and capsules according to a randomized two way cross over design. The concentration of metformin in serum was determined by HPLC. The pharmacokinetic parameters were processed with NDST program for variance analysis and two one-side t test. RESULTS: The main pharmacokinetic parameters were as follows: c max were (2.61±0.85),(2.41±0.84) mg·L -1, t max were (3.13±0.78),(3.48±0.95) h, T 1/2 were(3.80±0.99),(3.29±0.54) h, AUC 0→16 were ( 13.95±3.97),(12.76±4.02) mg·h·L -1, AUC 0→∞ were (14.78±3.97),(13.42±4.18) mg·h·L -1, respectively. The statistic results showed no significant differences between 2 preparations. CONCLUSION: The 2 preparations are bioequivalent.