摘要
目的:研究2种双氯芬酸钾胶囊的人体生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服受试制剂或参比制剂,采用高效液相色谱-质谱法测定血药浓度,计算药动学参数和相对生物利用度。结果:受试制剂与参比制剂的药-时曲线符合一房室模型,AUC0～8分别为(2.27±0.66)、(2.16±0.58)(μg·h)/ml,Cmax分别为(1.27±0.40)、(1.38±0.58)μg/ml,tmax分别为(0.9±0.7)、(1.0±0.7)h;受试制剂的相对生物利用度为(104.9±12.8)%。结论:2种双氯芬酸钾胶囊具有生物等效性。
OBJECTIVE： To study the bioequiavailability of 2 kinds of diclofenac potassium capsules in human body.METHODS：The blood concentrations of the 20 healthy male volunteers were determined by HPLC-MS; the pharmacokinetics and the bioequiavailability in whom were calculated after orally taking by randomized crossover way single dose of trial capsule and reference capsule. RESULT： The concentration-time curves of the trial capsules and the reference capsules were in conformity with one-compartment model. The experiment data showed that the AUC0-8 of the 2 kind of capsules were（2.27±0.66）,（2.16±0.58）（μg·h）/ml, respectively; their Cmax were （1.27±0.40） and （1.38±0.58）μg/ml, respectively;their tmax were （0.9±0.7）, （1.0±0.7）h, respectively. The relative bioavailability of the trial capsules was （104.9±12.8） %.CONCLUSION： The 2 kinds of diclofenac potassium capsules are bioequivalent.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第15期1157-1159,共3页
China Pharmacy
