摘要
目的：对比研究国产与进口酒石酸关托洛尔片的人体药代动力学，评价两者的生物等效性。方法：按照国家食品药品监督管理局颁布条例，选择18～40岁健康成年男性20名，采用随机交叉实验设计，应用高效液相一荧光检测方法测定健康志愿者分别应用国产与进口酒石酸关托洛尔片口服给药0．1g后各时血药浓度，应用DAS软件计算药代动力学参数。结果：采用高效液相一荧光检测方法测定血药浓度对酒石酸美托洛尔进行临床药代动力学研究，方法灵敏、可靠、准确、可行。国产酒石酸美托洛尔片与进口制剂的主要药代动力学参数：Tmax为1．11±0．36h、1．39±0．65h；Cmax为269±87、262±76μg·L^-1；AUC0-12h为1088．91±510．52、1098．29±555．14μg·L^-1·h。国产酒石酸美托洛尔片相对参比制剂的人体相对生物利用度为100．09％。结论：国产酒石酸美托洛尔片与进口制剂生物等效。
AIM： To study the bioequivalence of domestic and imported Metoprolol Tartrate Tablets in Chinese healthy volunteers. METHODS： According to the rule published by SFDA, the serum concentration of 20 selected volunteers among 18 to 40 years old was determined by HPLC-fluorescence detection after giving domestic and imported Metoprolol Tartrate Tablets 0. 1g, and the phannacokinetic parameters were calculated by DAS software. RESULTS： The method of HPLC-fluorescence detection to study the pharmakokinetics of Metoprolol Tartrate was sensitive, reliable, accurate and reasonable.The main pharmakokinetics parameters of domestic and imported Metoprolol Tartrate Tablets were Tmax ： 1.11 ± 0.36 h and 1.39 ± 0.65 h respectively; Cmax ： 269.20 ± 87. 15 μg· L^- 1 and 262.03 ± 75.52 μg· L^- 1 respectively; AUC0-12h： 1088.91 ±510.52 μg·L^-1·h and 1098.29± 5 55.14 μg· L^-1 · h respectively. The relative bioavailability of domestic Metoprolol Tartrate Tablets was 100.09 %. CONCLUSION： The domestic and imported Metoprolol Tartrate Tablets was bioequivalents.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2006年第9期1043-1047,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics
