氨酚双氢可待因胶囊在健康人体的生物等效性OA北大核心CSCDCSTPCD

Objective To study the bioequivalence of paracetamol and dihydrocodeine tartrate capsules in healthy volunteers.Methods A single oral dose of tested and reference formulation were given to 20 healthy volunteers in a randomised crossover study.The concentrations of acetaminophen and dihydrocodeine in plasma were determined by HPLC, respectively.The pharmacokinetic parameters were calculated and the bioavailability and bioequivalence of acetaminophen and dihydrocodeine were evaluated by DAS program.Results After a single dose, the pharmacokinetic parameters for acetaminophen were as follows: Cmax were (9.06 ±2.05) and (9.15 ±2.50) mg· L-1; AUC0-14were (34.46 ±7.49) and (35.91 ±7.01) mg · h · L-1; AUC0-∞ were (35.66 ±7.86) and (37.24 ± 7.56) mg· h · L- 1 for tested and reference formulation, respectively.The relative bioavailability was (97.17 ± 19.09)％The pharmacokinetic parameters for dihydrocodeine were as follows:Cmax were (61.84 ±9.84) and (58.33 ±6.79) μg · L-1; AUC0-14 were (289.23 ±31.30) and (281.56 ±25.91) μg · h · L-1; AUC0-∞ were (304.83 ±32.95) and (298.45 ±29.15) μg · h · L-1 for tested and reference formulation, respectively.The relative bioavailability was ( 103.58 ± 15.09) ％.Conclusion The results of the statistic analysis showed that the two formulations were bioequivalence.