高脂高熱量飲食對頭孢呋辛酯片藥動學(xué)的影響
發(fā)布時間:2018-04-04 10:57
本文選題:頭孢呋辛酯 切入點:高脂肪高熱量飲食 出處:《中國藥學(xué)雜志》2017年17期
【摘要】:目的研究高脂肪高熱量飲食對頭孢呋辛酯在健康受試者體內(nèi)的藥動學(xué)的影響。方法采用隨機(jī)、開放、單劑量給藥、雙交叉試驗設(shè)計。12例健康男性受試者隨機(jī)分為兩組,每組6人,分別空腹和餐后服用頭孢呋辛酯片250 mg,給藥前后按不同采血時間點采集血樣,采用液相色譜-質(zhì)譜聯(lián)用(HPLC-MS/MS)法測定血漿中頭孢呋辛濃度,用DAS3.2.8軟件計算藥動學(xué)參數(shù),并用DAS3.2.8軟件和SPSS19.0軟件對其主要參數(shù)進(jìn)行統(tǒng)計分析。結(jié)果空腹與餐后的主要藥動學(xué)參數(shù)如下:AUC_(0-t)分別為(11 402.8±3 556.7)和(18 565.7±2 917.9)ng·h·mL~(-1),AUC_(0→∞)分別為(11 492.5±3 581.8)和(18 754.7±2 885.6)ng·h·mL~(-1),ρ_(max)分別為(3 406.7±1 188.9)和(5 439.2±1 118.2)ng·mL~(-1),t_(max)分別為(2.01±0.64)和(2.08±0.79)h,t_(1/2)分別為(1.66±0.38)和(1.60±0.60)h。用SPSS19.0軟件對空腹和餐后給藥的主要藥動學(xué)參數(shù)進(jìn)行統(tǒng)計分析,AUC_(0-t)、AUC_(0→∞)和ρ_(max)具有顯著性差異(P0.01),t_(max)與t_(1/2)無統(tǒng)計學(xué)意義(P0.05)。ρ_(max)、AUC分別升高了59.7%和63.2%,t_(max)幾乎不變。用DAS3.2.8軟件進(jìn)行等效性分析,AUC_(0-t)比值(餐后/空腹)的90%置信區(qū)間為137.6%~217.5%,AUC_(0→∞)比值(餐后/空腹)的90%置信區(qū)間為138.4%~217.3%,ρ_(max)比值(餐后/空腹)的90%置信區(qū)間為135.4%~207.6%,均不在80%~125%等效區(qū)間內(nèi)。結(jié)論高脂高熱量飲食可顯著提高頭孢呋辛酯片在人體內(nèi)的吸收程度,但不影響其吸收速度。
[Abstract]:Objective to study the pharmacokinetics of cefuroxime in healthy volunteers with high fat and high calorie diet.Methods A randomized, open, single-dose, double-cross trial design was used to divide 12 healthy male subjects into two groups, 6 in each group.Cefuroxime was taken on an empty stomach and 250 mg after meal. Blood samples were collected at different time points before and after administration. The concentration of cefuroxime in plasma was determined by liquid chromatography-mass spectrometry (LC-MS / MS), and the pharmacokinetic parameters were calculated by DAS3.2.8 software.The main parameters are analyzed by DAS3.2.8 and SPSS19.0 software.緇撴灉絀鴻吂涓庨鍚庣殑涓昏鑽姩瀛﹀弬鏁板涓,
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