拉氧头孢单次给药药代动力学研究

SINGLE DOSE PHARMACOKINETICS STUDY ON LATAMOXEF IN NORMAL VOLUNTEERS

本研究对８例健康男性志愿受试者，进行了拉氧头孢粉针剂ｉｖ与ｉｍ两种给药方式的药代动力学研究。给药剂量均为１０００ｍｇ，测定方法为微生物测定法和高压液相测定法平行进行，数据用３Ｐ８７计算机程序处理。结果显示，血药浓度数据符合二室开放模型，两种测定方法所得结果相似，ｉｖ最高浓度分别为１２２．９ｍｇ／１和１５０．１ｍｇ／ｌ。Ｔ_（１／２）β分别为２．９４和２．５４ｈ。Ｃｌｓ分别为２．３９和３．２６ｍｌ／ｍｉｎ。ＡＵＣ分别为４３０．７和３２２．８ｍｇ·ｌ^（－１）·ｈ^（－１）。Ｖ分别为８．６２和８．９６１。ｉｍ峰浓度分别为５４．１和５６．８ｍｇ／ｌ，达峰时间分别为１．１１和１．４９ｈ。Ｔ_（１／２）β分别为３．３７和２．７４ｈ。Ｔ_（１／２）Ｋａ分别为０．４７和０．５６ｈ。Ｃｌｓ分别为２．３４和３．７５ｍｌ／ｍｉｎ。ＡＵＣ分别为３２９．０和３０９．７ｍｇ·ｌ^（－１）·ｈ^（－１）。Ｖ分别为１２．７和１０．２１。结果表明两种测定方法所得结果没有明显差异。

A crose over clinical pharmacokinetic study on latamoxef(shiomarin)was carried out in 8 normal male colunteers.1000 mg of latamoxef was fiven by iv or im injection.The concentrations of latamoxef in serum were detected by bioassay and HPLC mothods performed siumltaneously,The pharmacokinetic parameters were analyzed by 3P87 computer software.The serum concentration-time curve of the drug measured by two methods fitted two-compartment open model.The mean peak serum concentrations obtained after intravenous injection were 122.9-150.1 mg/l.The maximum serum concentration observed after intramuscuiar injection were 54.1-56. 8 mg/l at 1.11(-1).49 h.T_(1/2)βwere 2.74-3.37h.The results were in conformity w1lh the literatures.There were no significant difference between two detecting methods.