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目的 :研究盐酸伪麻黄碱 (Pse)缓释片的相对生物利用度及稳态药物动力学。方法 :12名健康志愿者单剂量或多剂量口服 Pse缓释片或普通片 ,用高效液相色谱法测定血药浓度。结果 :Pse缓释片的相对生物利用度为 (10 0 .3± 7.496 ) %。多剂量口服 Pse缓释片和普通片稳态药物动力学参数 AU C(0→ t) :(5 6 2 6± 980 .8)和 (1393± 2 11.0 ) ng· h/ m l,cmin:(110 .0±2 6 .37)和 (115 .3± 2 4.6 1) ng/ ml,cmax:(394.1± 5 6 .79)和 (4 2 7.9± 96 .0 9) ng/ m l以及 FI∶ 1.12 6± 0 .179和 1.19± 0 .137。结论 :研制的 Pse缓释片可缓释 2 4h,并与口服 6 0 mg,q6 h普通片生物等效。其主要药物动力学参数与国外文献报道的基本一致
Objective: To study the relative bioavailability and steady-state pharmacokinetics of pseudoephedrine hydrochloride (Pse) sustained-release tablets. Methods: Twelve healthy volunteers were given oral or multi-dose oral Pse sustained-release tablets or normal tablets, and the plasma concentration was determined by HPLC. Results: The relative bioavailability of Pse sustained-release tablets was (100.3 ± 7.496)%. The steady-state pharmacokinetic parameters AU C (0 → t): (562 ± 6 ± 980 .8) and (1393 ± 2 11.0) ng · h / ml for multidose oral Pse sustained- 110 ± 0.2 6 .37) and (115.3 ± 2 4.6 1) ng / ml, cmax: (394.1 ± 56.79) and (42.9 ± 96.09) ng / 1.12 6 ± 0.179 and 1.19 ± 0.137. CONCLUSION: Pse sustained-release tablets can be sustained-released for 24 hours and are bioequivalent to common tablets administered 60 mg and q6 h orally. The main pharmacokinetic parameters are basically consistent with those reported in foreign literature