氨糖美辛的2种肠溶片在健康男性志愿者的药动学和生物等效性比较

目的:研究2种氨糖美辛肠溶片在人体的 药动学过程及其生物等效性。方法:吲哚美辛血药 浓度用高压液相色谱法检测,20名健康男性志愿者 随机分组、自身交叉口服300mg氨糖美辛肠溶片。 结果:试验制剂和参比制剂的主要药动学参数tmax: (3.5±s0.9)和(3.3±0.9)h;cmax:(5.9±2.0)和 (6.1±1.6)mg·L-1;t12ke:(7.6±2.0)和(7.5± 2.9)h;AUC0～24:(18±4)和(16±3)mg·L·h-1;AUC0～∞:(19±4)和(18±4)mg·L·h-1。相对生 物利用度F0～24,F0～∞分别为(109±14)%和(111± 17)%。结论:试验制剂和参比制剂生物等效。

Pharmacokinetics and bioequivalence of two kinds of glucosamine indometacin enteric-coated tablets in Chinese male volunteers

AIM:To study the pharmacokinetics and bioequivalence of glucosamine indometacin enteric-coated tablets (po) in male volunteers. METHODS: The indometacin concentrations in plasma were determined by HPLC-UV. The test and reference formulations of glucosamine indometacin enteric-coated tablets were given to 20 healthy male volunteers by randomized crossover, respectively. RESULTS: After a single oral dose of 300 mg glucosmine indometacin enteric-coated test or reference tablets was taken the main pharmacokinetic parameters of indometacin AUC 0-24, AUC 0-∞, t max, c max and t 1/2 were (18±s 4) and (16±3) mg· L·h -1,(19±4) and (18±4) mg·L·h -1,(3.5±0.9) and (3.3±0.9) h, (5.9±2.0) and (6.1±1.6) mg·L -1,(7.6± 2.0) and (7.5±2.9)h respectively. The relative bioavailability F 0-24,F 0-∞ were (109±14) % and (111±17) %. CONCLUSION: No significant difference exists among the pharmacokinetic parameters for the experimental tablets and the reference. The two formulations were bioequivalent.