健康人口服对乙酰氨基酚滴剂的药代动力学及生物利用度研究

Pharmacokinetics and Bioavailability Study on Acetaminophen Oral Drop in Healthy Volunteers

作者利用高效液相色谱法测定８名健康自愿受试者交叉口服对乙酰氨基酚滴剂和片剂１０００ｍｇ以后，血浆中对乙酰氨基酚的浓度，所得药－时曲线均符合二室模型。平均达峰时间分别是０．８６±０．０８和１．４８±０．３９ｈ，平均血浆药物峰浓度分别是１１．２３±０；９３和８．７９±０．９３ｍｇ／Ｌ平均消除半衰期分别为３．０３±０．７９和２．５１±１．１０ｈ，平均曲线下面积分别为４２．３５±６．２０和４０．６０±６．７９ｍｇ／Ｌ·ｈ，以片剂的ＡＵＣ为１００％，口服滴剂的相对生物利用度为１０５．５８％。结果表明：这两种制剂在人体内具有生物等效性。

The concentrations of acetaminophenin human Dlasma were determined by RP-HPLC afteradministration of a single oral dose of 1000 mg ac-etaminophen oral drop or tablet to eight normal malevolunteers in a crossover study. The concentration vstime curves of acetaminoohen all fitted the two com-partment model.The C_(max) in oral drop and tablet were11.23±0.93and 8. 79±0.93 jmg/L,respectively;T_(max)were 0.86±0.08 and 1.48±0.39h;T_(1/2)β3.03±0.79and 2. 51±1.10 h; AUC 42.35±6.20 and 40.60±6. 79mg/L·h. When AUC in tablet was 100/,therelative bioavailability of acetaminophen oral drop was105.58%.The results showed that the oral drop andtaHet are bioeouivalent.