三种国产苯妥英制剂的生物利用度分析

BIOAVAILABILITY OF THREE PHENYTOIN FORMULATIONS MADE IN CHINA

对10名健康受试者,测定了国产苯妥英口服片剂、口服混悬剂,肌注水针剂的生物利用度。用HPLC法测得的血药浓度数据,按PCNONLIN程序进行曲线拟合,计算AUC;再按AUC/AUC计算绝对生物利用度,结果口服片剂、混悬剂及肌注水针剂的绝对生物利用度分别为71.0±13.9%,68.1±16.6%及30.5±12.0%。t测验表明口服片剂及肌注水针剂间吸收程度的差异非常显著(p<0.01)。

The bioavailabilities of three phenytoin formulations made inChina were determined in 10 healthy volunteers.The plasma phenytoin concen-trations were determined by HPLC method,and C-t data were curve-fitted byPCNONLIN program.The absolute bioavailabilities were 71.0±13.9%,68.1±16.6%and 30.5±12.0%for oral tablets,oral suspension and intramuscularainjection solution respectively.The difference in absorption between oral tabletsand intramuscular injection solution was very significant(p<0.01)