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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
Abstract：AIM: To study the bioavailability and steady state pharmacokinetics of sustained release pseudoephedrine (Pse) tablet. METHODS: A single dose or multi dose of Pse was given to 12 healthy volunteers. Plasma levels were determined by high performance liquid chromatogrphy. RESULTS: The relative bioavailability of sustained release Pse was (100 3±7 496)%. Pharmacokintic parameters of the multi dose of sustained released Pse and conventional Pse tablet were AUC (0→t) : ( 5 626 ±980 8) and ( 1 393 ±211 0) ng·h/ml, c min :(110 0±26 37) and (115 3±24 61) ng/ml, c max : (394 1±56 79) and (427 9±96 09) ng/ml, and FI∶1 126±0 179 and 1 19±0 137, respectively. CONCLUSION: The sustained release Pse tablet can release for 24 h, and is the same effective as the conventional Pse tablet with 60 mg q6 h. The pharmacokinetic parameters are similar to those reported.
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基本信息:
DOI：10.19577/j.cnki.issn10074406.2000.05.008
中图分类号:R96
引用信息:
[1]钟明康,施孝金,张静华,王宏图.盐酸伪麻黄碱缓释片的相对生物利用度和稳态药物动力学[J].中国临床药学杂志,2000(05):286-289.DOI:10.19577/j.cnki.issn10074406.2000.05.008.
2000-10-25
2000-10-25