Study on the Relative Bioavailability of Yifuxian'an Capsules in Human Body
Guo Yan-rong
Abstract
Guo Yan-rong
Abstract
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.
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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.
Key concepts: Bioavailability, Bioequivalence, Pyrazinamide, Rifampicin, Pharmacokinetics, Isoniazid, Chemistry, Chromatography