赖氨匹林胶囊的相对生物利用度

THE RELATIVE BIOAVAILABILITY OF LYSIN ASPIRIN CAPSULES IN HEALTHY VOLUNTEERS

采用反相高效液相色谱法测定１０名志愿受试者单剂量口服１０００ｍｇ赖氨匹林胶囊和５００ｍｇ阿司匹林肠溶片后，血浆中水杨酸浓度变化情况经３Ｐ８７非室模型药动学程序处理，结果表明，口服１０００ｍｇ赖氨匹林胶囊后，在水杨酸计的药时曲线下面积、达峰时间及峰浓度与阿司匹林肠溶片相比均无显著性差异（Ｐ＞０．０５）。说明赖氨匹林胶囊和阿司匹林肠溶片为生物等效制剂。以水杨酸计的相对生物利用度为（１０２．３０±７．４６）％。

The Salicylic Acid concentrations in plasma were determined by HPLC method following a single dose of Lysin Aspirin Capsule and Aspirin Enteric Tablet was given respectively to 10 volunteers in a open randomized cross over test. The AUC 0→∞ were (254 66±36 19)mg/L×h and (226 71±30 92) mg/L×h;T max were(3 6±0 66)h and (3 8±0 42)h;C max were(50 59±7 43)mg/L and (42 72±3 68)mg/L for Lysin Aspirin Capsule and Aspirin Enteric Tablet repectively.The results of the pair test showed that there were no significant differences between two formulations in the AUC 0→∞ 、T max and C max .These two formulations were bioequivalent. The relative bioavailability of Lysin Aspirin Capsule was 102.30%.