甲磺酸多沙唑嗪片在健康人体内的生物等效性研究

Bioequiavailability of Doxazosin Mesylate Tablets in Healthy Volunteers

目的:评价2种甲磺酸多沙唑嗪片生物等效性。方法:20名健康男性受试者自身交叉单剂量口服甲磺酸多沙唑嗪片受试制剂与参比制剂各4mg后,用高效液相色谱(HPLC)-荧光检测法测定血药浓度,计算其主要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Cmax分别为(39.31±6.04)、(31.83±6.33)ng.mL-1,tmax分别为(2.00±0.83)、(2.25±0.70)h,t1/2分别为(14.12±4.55)、(15.13±4.66)h,AUC0～72分别为(449.14±101.12)、(430.25±118.10)ng.h.mL-1,AUC0～∞分别为(457.09±105.92)、(439.40±121.83)ng.h.mL-1。受试制剂相对于参比制剂的生物利用度为(108.75±23.06)%。结论:两制剂具有生物等效性。

OBJECTIVE： To study the bioequiavailability of two kinds of doxazosin mesylate tablets in the healthy volunteers. METHODS： A single oral dose of test doxazosin mesylate（4 rag） and reference doxazosin mesylate （4 mg） were given to 20 health volunteers by self - control crossover design. Plasma drug concentrations were determined by HPLC - fluorescence detection. The pharmacokinetie parameters of the two preparations and the relative bioavailability were computed. RESULTS： The main pharmacokinetic parameters of the test preparation vs. reference preparation were as follows： Cmax（39.31 ± 6.04） ng.mL^-1 vs. （31.83±6.33） ng.mL^-1 tmax（2.00±0.83） h vs. （2.25±0.70） h; t1/2（14.12± 4.55） hrs. （15.13±4.66） h; AUC0-72（449.14±101.12） ng·h· mL^-l vs.（430.25±118.10） ng.h.mL^-1; AUC0-∞ （457.09± 105.92） ng·h·mL^-1 vs. （439.40 ± 121.83） ng·h·mL^-1. The relative bioavailability of the test preparation was （108.75 ± 23.06）%. CONCLUSION： The two preparations are bioequivalent.