高脂高热量饮食对头孢呋辛酯片药动学的影响

发布时间：2018-04-04 10:57

  本文选题：头孢呋辛酯　切入点：高脂肪高热量饮食　出处：《中国药学杂志》2017年17期

【摘要】：目的研究高脂肪高热量饮食对头孢呋辛酯在健康受试者体内的药动学的影响。方法采用随机、开放、单剂量给药、双交叉试验设计。12例健康男性受试者随机分为两组,每组6人,分别空腹和餐后服用头孢呋辛酯片250 mg,给药前后按不同采血时间点采集血样,采用液相色谱-质谱联用(HPLC-MS/MS)法测定血浆中头孢呋辛浓度,用DAS3.2.8软件计算药动学参数,并用DAS3.2.8软件和SPSS19.0软件对其主要参数进行统计分析。结果空腹与餐后的主要药动学参数如下:AUC_(0-t)分别为(11 402.8±3 556.7)和(18 565.7±2 917.9)ng·h·mL~(-1),AUC_(0→∞)分别为(11 492.5±3 581.8)和(18 754.7±2 885.6)ng·h·mL~(-1),ρ_(max)分别为(3 406.7±1 188.9)和(5 439.2±1 118.2)ng·mL~(-1),t_(max)分别为(2.01±0.64)和(2.08±0.79)h,t_(1/2)分别为(1.66±0.38)和(1.60±0.60)h。用SPSS19.0软件对空腹和餐后给药的主要药动学参数进行统计分析,AUC_(0-t)、AUC_(0→∞)和ρ_(max)具有显著性差异(P0.01),t_(max)与t_(1/2)无统计学意义(P0.05)。ρ_(max)、AUC分别升高了59.7%和63.2%,t_(max)几乎不变。用DAS3.2.8软件进行等效性分析,AUC_(0-t)比值(餐后/空腹)的90%置信区间为137.6%~217.5%,AUC_(0→∞)比值(餐后/空腹)的90%置信区间为138.4%~217.3%,ρ_(max)比值(餐后/空腹)的90%置信区间为135.4%~207.6%,均不在80%~125%等效区间内。结论高脂高热量饮食可显著提高头孢呋辛酯片在人体内的吸收程度,但不影响其吸收速度。
[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.缁撴灉绌鸿吂涓庨�愬悗鐨勪富瑕佽嵂鍔ㄥ�﹀弬鏁板�備福�

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