Hamaguchi T, Shinkuma D, Yamanaka Y, Mizuno N
J Pharmacobiodyn. 1987 Jan;10(1):21-5. doi: 10.1248/bpb1978.10.21.
The influence of food on the bioavailability of mefenamic acid from two commercial capsules (products A and B) differing in bioavailability was studied with four healthy male volunteers. The drug was administered as a single oral dose of 250 mg under fasting and nonfasting conditions. The study used a 4 X 4 Latin-square design. Seven blood samples were collected over a 9-h period following administration and the plasma concentrations of mefenamic acid were determined by a high performance liquid chromatographical method. The bioavailability was significantly different between the two products in the fasting condition, agreeing with the result of an in vitro dissolution study. However, in the nonfasting state, the difference was not significant because the product showing poor bioavailability, product A, in the nonfasting state showed marked improvement. On the other hand, the product showing good bioavailability, product B, was not affected by food.
利用四名健康男性志愿者,研究了食物对两种生物利用度不同的市售胶囊(产品A和产品B)中甲芬那酸生物利用度的影响。药物在禁食和非禁食条件下均以250mg的单次口服剂量给药。该研究采用4×4拉丁方设计。给药后9小时内采集7份血样,采用高效液相色谱法测定甲芬那酸的血浆浓度。在禁食条件下,两种产品的生物利用度有显著差异,这与体外溶出度研究结果一致。然而,在非禁食状态下,差异不显著,因为在非禁食状态下生物利用度较差的产品A有显著改善。另一方面,生物利用度良好的产品B不受食物影响。