法莫替丁药代动力学研究

THE PHARMACOKINETICS OF FAMOTIDINE IN HEALTHY VOLUNTEERS

本文进行了分别由三个厂家生产的法莫替丁在１０例正常志愿者中的药代动力学研究。１０例正常志愿者交叉口服由温州，青岛及国外生产的２片法莫替丁片（每片２０ｍｇ），用ＨＰＬＣ法测定法莫替丁的血浆浓度和回收率。研究结果表明：药代动力学符合开放性二室模型。主要药代动力学参数如下：温州组：Ｔ_（ｐｅａｋ）＝２．０１±０．３４ｈ，Ｃ_（ｍａｘ）＝１６６．１０±４２．９６μｇ·ｈ^（－１）·Ｌ^（－１），Ｔ_（１／２）β＝２．３８±０．５２ｈ，ＣＬｒ＝１２．０６±２．１８ｌ／ｈ，ＡＵＣ＝９２０．２０±１３０．００μｇｈ^（－１）·Ｌ^（－１）；青岛组：Ｔ_（ｐｅａｋ）＝１．８７±０．３４ｈ，Ｃ_（ｍａｘ）＝１７７．０８±３３．３８μｇ·ｈ^（－１）·Ｌ^（－１），Ｔ_（１／２）β＝２．６４±０．６９ｈ，ＣＬｒ＝１２．０７±２．２５ｌ／ｈ，ＡＵＣ＝９３７．２３±１１７．００μｇ·ｈ^（－１）·Ｌ^（－１）；国外组：Ｔ_（ｐｅａｋ）＝１．９４±０．５８ｈ，Ｃ_（ｍａｘ）＝１６５．８０±３８．１３μｇ／１，Ｔ_（１／２）β＝２．５１±０．６１ｈ．Ｃｌｒ＝１２．０４±２，４２１／ｈ，ＡＵＣ＝８９４．３３±１３０．７３μｇ·ｈ^（－１）·Ｌ^（－１）。

The pharmacokinetics of famotidine produced by Wenzhou,Qingdao,foreign pharmaceutica respectively was studied in ten healthy male volunteers after oral administration of two tablets(40mg).Famotidine concentration was determined by HPLC.The plasma level-time curve of famotidine was fitted to two-compartment open model.The pharmacokinetic parameters of famotidine are as follows:Wenzhou(T1):T_(peak)=2.01±0.34h.C_(max)=166. 10±42.96μg/l,AUC=920.20±130,00μg·h￣(-1)·L￣(-1),T_(1/2)β=2.38±0.52h,Clr=12.06±2.18 l/h; Qingdao(T2):Tpeak=1.87±0.34h,C_(max)=177.08±33.38 μg/1. AUC=937. 23±117.00μg·h￣(-1)·L￣(-1),T1/2β=2. 64±0. 69h.Clr=12.07±2.25 l/h; Foreign(T3):T_(peak)=1.94±0.58h.C_(max)=165.80±38.13 μg/l.AUC=894.33±130.73μg·h￣(-)·L￣(-1),T_(1/2)β=2.51±0.61h,Clr=12.04±2.42 l/h;relative bioavailability:F T1/T2(%) = 98.35±10.88%;F T1/T3(%)=102.95±13.35%