Pharmacokinetics and relative bioavailability of compound rifampin tablet

Objective The pharmacokinetics and relative bioavailability of two compound rifampin tablets were studied.Methods Isoniazid and pyrazinamide were determined after a single oral dose of test or reference preparation was given respectively to 12 volunteers in an open randomized cross-over test.The concentrations of isoniazid and pyrazinamide in plasma were assayed by RP-HPLC method.Restults The AUC_(0→∞),T_(max) and C_(max) of isoniazid in the two preparations were(43.97 ± 16.81)mg·h~(-1)·ml~(-1) and(43.18 ± 16.33)mg·h~(-1)·ml~(-1),1.79 ± 0.54 h and(1.63 ± 0.38)h,(8.39 ±4.30)mg/ml and(8.36 ± 4.52)mg/ml respectively.The AUC_(0→∞),T_(max) and C_(max) of pyrazinamide in the two formations were(569.87±271.30)mg·h~(-1)·ml~(-1) and((563.55)±262.48)mg·h~(-1)·ml~(-1),(1.68 ± 0.58)h and(1.50±0.30)h,(34.38±14.55)mg/ml and(36.23±13.47)mg/ml respectively.The result of statistical analysis showed that there were no significant difference of the AUC_(0→∞),T_(max) and C_(max) of isoniazid and pyrazinamide between the two formations(P0.05).Conclusion Two compound rifampin tablets were bioequivalent using AUC_(0→∞),T_(max) and C_(max) of isoniazid and pyrazinamide as evaluated factors.The relative bioavailability of isoniazid and pyrazinamide for test tablet were(101.73±5.95)% and(100.28±10.50)% respectively.