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目的：研究了１０ 名男性健康志愿者单剂量ｐｏ 两种对乙酰氨基酚（ 扑热息痛）异型片５００ ｍｇ 的药代动力学和相对生物利用度。方法：按照随机交叉试验设计，采集服药后０－５ ，１，１－５ ，２ ，３ ，４，６，８，１０ ｈ 的血样本，用ＨＰＬＣ测定扑热息痛的血药浓度。结果：两种制剂的药时曲线符合口服吸收有滞后时间的一级动力学一室模型。受试制剂扑热息痛薄膜包衣异型片（ 康司达） 的主要药代动力学参数：ｃｍａｘ＝ （５－５１ ±１－２４）ｍｇ·Ｌ－１ ，ｔｍａｘ＝ （１－０３ ±０－４３）ｈ ，ｔ１／２ｋａ＝ （０－２７ ±０－１６）ｈ ，ｔ１／２ｋｅ ＝（２－６０ ±０－５１）ｈ，ＡＵＣ０～∞＝ （３４－９１ ±７－９６）ｍｇ·ｈ·Ｌ－１ ，ＭＲＴ＝ （３－６５ ±０－２２）ｈ。参比制剂（ 必理通） 的主要药代动力学参数：ｃｍａｘ ＝ （５－８１ ±１－０１）ｍｇ·Ｌ－ １ ，ｔｍａｘ ＝（０－８８ ±０－３２）ｈ，ｔ１／２ｋａ ＝ （０－１４ ±０－０７）ｈ，ｔ１／２ｋｅ ＝ （２－７１ ±０－９３）ｈ，ＡＵＣ０ ～∞＝ （３３－１４ ±５－６７）ｍｇ·ｈ·Ｌ－１ ，ＭＲＴ＝ （３－６０ ±０－１０）ｈ。两种片剂药代动力学参数（除ｔ１／２ｋａ 值外）均无显著
AIM: To investigate the pharmacokinetics and relative bioavailability of two 500 mg acetaminophen (acetaminophen) isoflurate tablets in 10 male healthy volunteers. Methods: According to the randomized crossover design, blood samples of 0-5, 1, 1-5, 2, 3, 4, 6, 8 and 10 h after taking the medicine were collected and the plasma concentrations of paracetamol were determined by HPLC. RESULTS: The drug-time curves of the two formulations were consistent with the first-order kinetic one-compartment model of oral absorption with a lag time. The main pharmacokinetic parameters of the test preparation paracetamol coated film (Kangstat): cmax = (5-51 ± 1-24) mg · L-1, tmax = (1-03 ± 0-43) h , T1 / 2ka = (0-27 ± 0-16) h, t1 / 2ke = (2-60 ± 0-51) h and AUC0 ~ ∞ = (34-91 ± 7-96) mg · h · L- 1, MRT = (3-65 ± 0-22) h. The main pharmacokinetic parameters of the reference formulation (BiLiTong): cmax = (5-81 ± 1-01) mg · L -1, tmax = (0-88 ± 0-32) h, t 1/2 ka = (0-14 ± 0-07) h, t1 / 2ke = (2-71 ± 0-93) h, AUC0 ~ ∞ = (33-14 ± 5-67) mg · h · L-1, MRT = 3-60 ± 0-10) h. Pharmacokinetic parameters of the two tablets (except t1 / 2ka value) were not significant