多潘立酮片人体药代动力学和生物等效性  

Pharmacokinetics and Bioequivalence of Domperidone in Healthy Volunteers

作　　者：石焱[1] 隋淼[1] 宋晓楠[1] 姚文[1] 

机构地区：[1]解放军第210医院药剂科,辽宁大连116021

出　　处：《临床军医杂志》2009年第2期285-287,共3页Clinical Journal of Medical Officers

摘　　要：目的研究多潘立酮片(湖南威特)在健康人体内的相对生物利用度和生物等效性,为新药报批及其临床应用提供依据。方法18名健康受试者采用随机双交叉试验方法,单剂量口服受试及参比制剂20 mg,用HPLC法测定给药后不同时间的血药浓度,计算主要药代动力学参数。结果受试制剂多潘立酮片(湖南威特)的T1/2:(9.31±1.60)h、Cmax:(27.2±2.5)μg/L、Tmax:(0.76±0.20)h、AUC0-t:(142.5±24.4)μg.h/L;参比制剂多潘立酮片(西安杨森)T1/2:(8.72±1.39)h、Cmax:(28.1±3.9)μg/L、Tmax:(0.78±0.21)h、AUC0-t:(140.9±27.3)μg.h/L。以AUC0-t计算,与参比制剂相比受试制剂中多潘立酮的平均相对生物利用度为(101.6%±5.1%)。结论两制剂生物等效。Objective To study the bioavailability and bioequivalence of domperidone （DMP） in healthy adult volunteers, provide information for the submission of the new drug and for its clinical application. Methods A randomized crossover design was used. Eighteen healthy aduh volunteers received a single oral dosage with 20 mg of trial preparation and reference preparation. Blood samples were collected at different time points. Plasma concentration of DMP was measured by high performance liquid chromatography （HPLC） method, and was calculated the main pharmacokinetic parameters. Results The trial preparation of dompendone（DMP） was detected as follows ： T1/2 = 9.31± 1.60 （ vs 8.72 ＋ 1.39 ） h, Cmax = 27.2 ± 2.5 （ vs 28.1 ±3.9 ） ng/ml, Tmax = 0.76 ±0.20 （ vs 0.78 ± 0.21 ） h, AUC0-4 = 142.5 ± 24.4 （vs 140.9 ± 27.3 ） ng · h/ml. Caeulated by AUC0-4, the average relative bioavail- ability was 101.6% ± 5.1%. Conclusion The two kinds of preparation are bioequibalent.

关 键 词：多潘立酮片 生物利用度 生物等效性 HPLC 

分 类 号：R975.4[医药卫生—药品]