Study on pharmacokinetics and bioequivalent evaluation of Yifuxianan tablets
Deng Li
Abstract
Deng Li
Abstract
OBJECTIVE To study the pharmacokinetics and relative bioavailability of two different kind of Yifuxianan tablets.METHODS Rifampicin and isoniazid and pyrazinamide were determined after a single oral do se of testing preparation Yifuxianan tablets and reference preparation Rifat er given respectively to 24 volunteers in an open randomized cross(over test. Ri fampicin and isoniazid and pyrazinamide concentration in plasma were assayed by RP-HPLC. RESULTS The results of statistical analysis showed that there were no significant differ ence of the AUC 0→t 、T max and C max of rifampicin and i soniazid and pyrazinamide between the two formations(P 0.05 ).CONCLUSIONS Yifuxianan tablets and Rafiter tablets were bioequivalent, the bioequivalenc e data of rifampicin, isoniazid and pyrazinamide of Yifuxianan tablets were ( 99.6 ± 13.0)% and( 104.1 ± 23.2)% and ( 102.2 ± 11.3)% using Rafiter tablets as reference preparation.
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OBJECTIVE To study the pharmacokinetics and relative bioavailability of two different kind of Yifuxianan tablets.METHODS Rifampicin and isoniazid and pyrazinamide were determined after a single oral do se of testing preparation Yifuxianan tablets and reference preparation Rifat er given respectively to 24 volunteers in an open randomized cross(over test. Ri fampicin and isoniazid and pyrazinamide concentration in plasma were assayed by RP-HPLC. RESULTS The results of statistical analysis showed that there were no significant differ ence of the AUC 0→t 、T max and C max of rifampicin and i soniazid and pyrazinamide between the two formations(P 0.05 ).CONCLUSIONS Yifuxianan tablets and Rafiter tablets were bioequivalent, the bioequivalenc e data of rifampicin, isoniazid and pyrazinamide of Yifuxianan tablets were ( 99.6 ± 13.0)% and( 104.1 ± 23.2)% and ( 102.2 ± 11.3)% using Rafiter tablets as reference preparation.
Key concepts: Bioequivalence, Pyrazinamide, Isoniazid, Rifampicin, Pharmacokinetics, Bioavailability, Pharmacology, Medicine