辛伐他汀片人体生物等效性研究

目的:比较2种辛伐他汀片的人体生物等效性。方法:20名健康受试者随机交叉单剂口服国产辛伐他汀片(受试制剂)与进口辛伐他汀片(参比制剂)40mg后,以高效液相色谱串联质谱电喷雾检测(LC-MS/MS)法测定血药浓度,利用3p97程序计算药动学参数和生物利用度。结果:2种辛伐他汀片在人体内药-时曲线符合一室模型,受试制剂与参比制剂药动学参数分别为:Cmax(13.23±4.41)、(12.68±4.43)ng.mL-1,tmax(1.64±1.20)、(1.54±1.28)h,AUC0~12(47.48±22.96)、(44.49±18.47)ng.h.mL-1,AUC0~∞(50.87±24.06)、(47.11±19.54)ng.h.mL-1。受试制剂的相对生物利用度为(106.72±15.20)%。结论:2种辛伐他汀片具有生物等效性。

Bioequivalence of Simvastain Tablets in Healthy Volunteers

OBJECTIVE： To compare the bioequivalence between two kinds of Simvastain Tablets. METHODS： A single dose of 40mg of domestic Simvastain Tablets （test preparation） and imported Simvastain Tablets （reference preparation） was administered by randomized crossover way in 20 healthy volunteers with plasma concentrations of simvastain determined by liquid chromatography mass spectrometry. The pharmacokinetic parameters were calculated with 3p97 pharmacokinetic program and the bioavailability was evaluated. RESULTS： The concentration time curve of two preparations fitted one compartment model. The pharmacokinetic parameters of the test preparation vs. the reference preparation were as follows： Cmax： （13.23±4.41） ng· mL^-1 vs. （12.68±4.43） ng· mL ^-1; tmax： （1. 64± 1.20） h vs. （1.54±1.28） h; AUC0-12： （47.48±22.96） vs. （44.49± 18.47） ng·h·mL ^-1; AUC0-∞：（50.87±24.06） ng·h·mL ^-1 vs. （47.11±19.54）ng·h·mL ^-1. The relative bioavailability of the test simvastain tablets was （106.72 ± 15.20）%. CONCLUSION： The results suggest that two preparations are bioequivalent.