IR@PKUHSC  > 北京大学第一临床医学院  > 临床药理研究所
其他题名Pharmacokinetics of multiple doses ampiroxicam in Chinese healthy subjects
赵彩芸; 吕媛; 魏敏吉; 康子胜; 刘燕; 张曼
关键词安吡昔康 吡罗昔康 药代动力学 高效液相色谱法 多次给药 Ampiroxicam Piroxicam Pharmacokinetic Hplc Multiple -dose
收录类别中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型Journal Article
摘要目的:评价安吡昔康片在中国健康受试者多次给药的药代动力学。方法随机、开放、多剂量给药设计的方法,12名受试者均多次口服安吡昔康片27 mg,每日1次,连续口服11 d,第8,9,10天给药前收集血样,第11天给药后在不同时间点收集血、尿样本,用 HPLC 法测定样品浓度。结果1名受试者在第7天退出试验,11名受试者进行了药代动力学统计分析,给药后主要药代动力学参数如下: Cmax 为(8.14±2.81) mg ? L -1; t1/2β为(50.10±18.10) h; tmax 为(5.60±4.10) h;AUC0-∞为(837.05±441.47) mg? h? L-1;0~192 h 尿中原型药物累积排泄百分率为(0.55±0.51)%。结论安吡昔康片多次给药后,由于药物半衰期很长,给药前存在一个非常高的谷浓度值,血药浓度和药代动力学参数有一定个体差异,药物尿液排泄量很少。 Objective To evaluate the pharmacokinetics of multiple doses of ampiroxicam tablets in Chinese healthy subjects .Methods A randomized, open study was conducted.Twelve subjects were orally administrated with 27 mg ampiroxicam tablets, once a day for 11 days. The blood samples were collected on the 8th , 9th , and 10th day before ad-ministration.On the 11 th day, the blood and urine samples were collected at different time points after administration , and the concentrations of am-piroxicam in serum and urine were determinated by HPLC method . Results One subject exited on the 7th day.The main pharmacokinetics parameters of 11 subjects after oral doses for 11 days were as follows:Cmax were(8.14 ±2.81) mg? L-1; t1 /2β was (50.10 ±18.10 ) h; tmax was (5.60 ±4.10) h; AUC0 -∞ was (837.05 ±441.47 ) mg? h? L respectively.Urinary recovery rate was (0.55 ±0.51 )% from zero to 192 hours, respectively.Conclusion After multiple dosing, there was a very high trough concentration before dosing because of a very long half -life of ampiroxicam.Blood concentration and pharmacokinetic parameters are individually different, and little drug is excreted by kidney.
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作者单位北京大学 第一医院 临床药理研究所,北京,100034
Recommended Citation
GB/T 7714
赵彩芸,吕媛,魏敏吉,等. 安吡昔康在健康受试者多次给药的药代动力学研究[J]. 中国临床药理学杂志,2014(10):915-918.
APA 赵彩芸,吕媛,魏敏吉,康子胜,刘燕,&张曼.(2014).安吡昔康在健康受试者多次给药的药代动力学研究.中国临床药理学杂志(10),915-918.
MLA 赵彩芸,et al."安吡昔康在健康受试者多次给药的药代动力学研究".中国临床药理学杂志 .10(2014):915-918.
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