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盐酸莫西沙星片在健康人体的药动学研究 被引量:12

Pharmacokinetics of Moxifloxacin Hydrochloride Tablet in Healthy Volunteers
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摘要 目的:研究盐酸莫西沙星片在中国健康人体内的药动学,为临床用药提供参考。方法:10名健康志愿者单剂量口服400 mg盐酸莫西沙星片后,HPLC-UV法测定血浆药物浓度,采用F检验结合AIC判断法进行房室模型判别,用DAS软件进行数据处理,采用房室模型法评估药动学参数。结果:最佳房室模型为二房室模型,主要药动学参数如下:C_(max)=(3.06±0.42)mg·L^(-1),t_(max)=(1.75±0.76)h,t_(1/2β)=(11.38±1.80)h,AUC_(0-t)=(32.45±6.48)mg·h·L^(-1),AUC_(0-∞)=(40.63±8.40)mg·h·L^(-1),V_(1/F)=(116.58±31.91)L,CL=(10.16±1.72)L·h^(-1)。除2例受试者出现可耐受的胃肠道不适外,无其他明显不良反应发生。结论:中国健康志愿者单剂量口服莫西沙星片后,耐受性良好,药动学参数与国外人体药动学参数基本一致,1日1次单次给药可迅速达到并维持有效血药浓度。 Objective: To study the pharmacokinetics of moxifloxacin tablet in Chinese healthy volunteers. Method: Ten healthy vol- unteers were orally administered a single dose of 400 mg moxifloxacin chloride tablet. The plasma concentration of moxifloxacin was determined by a validated HPLC-UV method. The best compartment model was judged by AIC criteria and F test. The data were processed with DAS software and assessed with compartment model to obtain the pharmacokinetic parameters. Result: The optimized compartment model was two-compartment model. The pharmacokinetic parameters were as follows : Cmax (3. 06 ±0. 42 ) mg. L- 1, tmax= ( 1.75 ± 0. 76) h, t1/2β ( 11.38 ± 1.80) h,AUCo4(32. 45 ±6. 48) mg·h·L-1 ,AUCo(40. 63±8.40) mg·h·L-1 ,V1/F( 116. 58 ±31.91 ) L,CL ( 10. 16 ± 1.72) L·h-1. Except for tolerable gastrointestinal discomfort in two volunteers ,no clinical significant changes were observed. Conclusion: Moxifloxacin tablet is well tolerated in Chinese healthy volunteers. The pharmacokinetic parameters are accordant with those from foreign popu-lations. Once-daily administration of 400mg moxifloxacin can acquire rapidly and maintain the effective plasma concentration.
出处 《中国药师》 CAS 2010年第6期793-796,共4页 China Pharmacist
基金 深圳市科技计划(医疗卫生类)项目(编号:200703224)
关键词 莫西沙星 血药浓度 药动学 Moxicifloxacin Plasma concentration Pharmacokinetics
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参考文献12

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二级参考文献25

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