异福酰胺胶囊人体相对生物利用度研究

目的:研究异福酰胺胶囊的人体生物等效性。方法:采用反相高效液相色谱法测定12名健康志愿受试者单剂量服用异福酰胺胶囊(受试制剂)或卫非特片(参比制剂)后的利福平、异烟肼和吡嗪酰胺血药浓度,药动学参数用3p97程序处理。结果:受试制剂与参比制剂的利福平AUC0～t 分别为(70. 69±36. 32)、(70. 77±32. 26) (μg·h)/ml,tmax 分别为(1 82±0 28)、(1 79±0 25)h ,Cmax 分别为(12 .83±4 .98)、(12 84±3 95) μg/ml;异烟肼AUC0～t 分别为(14. 30±8.25)、(13 .76±6 .16) (μg·h)/ml,tmax 分别为(1 54±0 36)、(1 58±0 38)h ,Cmax 分别为(5 .42±2 .52)、(5. 46±2 .46) μg/ml;吡嗪酰胺AUC0～T 分别为(243 .56±128. 98)、(238 .07±11. 63) (μg·h)/ml,tmax 分别为(1. 58±0. 64)、(1. 69±0 .55)h ,Cmax 分别为(29.45±12 .45)、(27 .46±11 .02) μg/ml。受试制剂中利福平、异烟肼和吡嗪酰胺的相对生物利用度分别为(99. 88±12. 92) %、(103 .84±24. 10) %、(102. 57±12. 31) %。结论:两种制剂具有生物等效性。

Study on the Relative Bioavailability of Yifuxian'an Capsules in Human Body

OBJECTIVE:To study the relative bioavailability of yifuxian'an capsules.METHODS:Concentrations of ri-fampicin,isoniazid and pyrazinamide in plasma were determined on12volunteers respectively after a single oral dose of yifux-ian'an capsules(tested preparations)and rifater(reference preparation)by RP-HPLC method;the pharmacokinetics parame-ters were processed by3p97process.RESULTS:The AUC 0～t of the tested preparation and reference substance of rifampicin were(70.69±36.32)and(70.77±32.26)(μg·h)/ml respectively,t max of which were(1.82±0.28)and(1.79±0.25)h re-spectively,C max of which were(12.83±4.98)μg/ml and(12.84±3.95)μg/ml respectively;The AUC 0～t of which were(14.30±8.25)and(13.76±6.16)(μg·h)/ml respectively,t max of which were(1.54±0.36)and(1.58±0.38)h respectively,C max of which were(5.42±2.52)and(5.46±2.46)μg/ml respectively;The AUC 0～t of which of pyrazinamide were(243.56±128.98)and(238.07±117.63)(μg·h)/ml respectively,t max of which were(1.58±0.64)and(1.69±0.55)h respectively,C max of which were(29.45±12.45)and(27.46±11.02)μg/ml respectively.The relative bioequivalence of rifampicin,isoniazid and pyrazi-namide of the tested preparation were(99.88±12.92)%,(103.84±24.10)%and(102.57±12.31)%respectively.CONCLU-SION:Bioavailability of the2preparations are bioequivalent.