丙吡胺不同剂型在健康人体内的生物利用度研究

Study on bioavailability of different dosage forms of disopyramide in healthy volunteers

应用HPLC法测定8名健康受试者单剂量口服丙吡胺不同剂型后的血药浓度。以丙吡胺溶液剂为参比制剂,比较了丙吡胺胶囊、片剂及缓释胶囊的相对生物利用度,并计算药物动力学参数。结果表明丙吡胺胶囊与片剂的药物动力学参数无显著差异(P>0.05);缓释胶囊的T_(max),C_(max)和Ka 显著改变(P<0.05),具有明显的缓释效果。三种剂型的相对生物利用度无显著差异(P>0.05)。

The plasma concentrations of disopyramide were determined in 8 healthy volunteers with HPLC after oral administrationof disopyramide solution(DS),capsules(DC),tablets(DT)and sustained release capsules(SRDC).The bioavailability of DC,DT and SRDC was compared with that of DS.The results showed that no significant difference was found in thepharmacokinetic parameters between DC and DT(P>0.05),while T_(max),C_(max) and K_a of SRDC changed significantly ascompared with DC(P<0.05).The relative bioavailability of DC,DT and SRDC after a single oral dose 300mg was98.02%,93.08% and 87.69% respectively and had no significant difference among three dosage forms(P>0.05).