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对乙酰氨基酚口服滴剂在健康志愿者中的药代动力学和生物利用度研究

[Pharmacokinetics and bioavailability study on acetaminophen oral drop in healthy volunteers].

作者信息

Hong Z, Li Z, Wang Y, Li L, Qiang W, Wang M, Zou J

机构信息

Military School of Chengdu Surgeon.

出版信息

Hua Xi Yi Ke Da Xue Xue Bao. 1994 Dec;25(4):410-3.

PMID:7744384
Abstract

The concentrations of acetaminophen in human plasma were determined by RP-HPLC after administration of a single oral dose of 1000 mg acetaminophen oral drop or tablet to eight normal male volunteers in a crossover study. The concentration vs time curves of acetaminophen all fitted the two compartment model. The Cmax in oral drop and tablet were 11.23 +/- 0.93 and 8.79 +/- 0.93mg/L, respectively; Tmax were 0.86 +/- 0.08 and 1.48 +/- 0.39h; T1/2 beta 3.03 +/- 0.79 and 2.51 +/- 1.10 h; AUC 42.35 +/- 6.20 and 40.60 +/- 6.79mg/L.h. When AUC in tablet was 100%, the relative bioavailability of acetaminophen oral drop was 105.58%. The results showed that the oral drop and tablet are bioequivalent.

摘要

在一项交叉研究中,给8名正常男性志愿者单次口服1000mg对乙酰氨基酚口服滴剂或片剂后,采用反相高效液相色谱法测定人血浆中对乙酰氨基酚的浓度。对乙酰氨基酚的浓度-时间曲线均符合二室模型。口服滴剂和片剂的Cmax分别为11.23±0.93和8.79±0.93mg/L;Tmax分别为0.86±0.08和1.48±0.39小时;T1/2β分别为3.03±0.79和2.51±1.10小时;AUC分别为42.35±6.20和40.60±6.79mg/L·h。以片剂的AUC为100%时,对乙酰氨基酚口服滴剂的相对生物利用度为105.58%。结果表明口服滴剂和片剂生物等效。

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