米诺膦酸片在中国男性健康受试者的生物等效性研究  

Bioequivalence study of minodronic acid tablets in Chinese healthy male subjects

作　　者：葛驰宇[1] 张君丽[1] 王江 GE Chi-yu;ZHANG Jun-li;WANG Jiang(School of Pharmacy,Jiangsu Food and Pharmaceutical Science College,Huaian 223005,Jiangsu Province,China;Department of Pharmacy,Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology,Wuhan 430030,Hubei Province,China)

机构地区：[1]江苏食品药品职业技术学院药学院,江苏淮安223005 [2]华中科技大学同济医学院附属同济医院药剂科,湖北武汉430030

出　　处：《中国临床药理学杂志》2020年第19期3103-3105,共3页The Chinese Journal of Clinical Pharmacology

基　　金：江苏省高等学校自然科学研究重大课题资助项目(18KJA360002)。

摘　　要：目的评价中国健康男性受试者空腹单剂量口服国产/进口米诺膦酸片后的生物等效性。方法本试验按开放、随机、双周期、双交叉方法进行设计。将24位男性健康受试者随机分为2组,分别单剂量口服米诺膦酸片受试制剂或参比制剂1 mg。用液相-质谱联用法测定血药浓度,用WinNonlin 6.0软件计算主要药代动力学参数,并评价两者的生物等效性。结果米诺膦酸片受试制剂和参比制剂的Cmax分别为(8.91±1.08)和(9.14±1.38)μg·mL^-1,tmax分别为(2.09±0.57)和(2.19±0.42)h,t1/2分别为(1.82±0.16)和(1.71±0.20)h,AUC0→∞分别为(16.75±3.27)和(17.21±2.95)μg·mL^-1·h。Cmax,AUC0→t和AUC0→∞的90%置信区间分别为86.9%~113.1%,97.0%~116.2%和88.1%~116.7%。结论米诺膦酸片受试制剂及参比制剂符合生物等效。Objective To evaluate the bioequivalence of domestic/imported minodronic acid tablets in Chinese healthy male subjects.Methods The experiment was designed according to the open,random,double period and double crossing mode.Twenty-four healthy male subjects were randomly divided into two groups,and given a single oral dose of minidronic acid tablet test or reference with 1 mg respectively.The plasma concentration was determined by liquid chromatography-mass spectrometry.The main pharmacokinetic parameters were calculated by WinNonlin 6.0 software,and the bioequivalence of the two drugs was evaluated.Results Cmax of minodronic acid tablets test or reference were(8.91±1.08)and(9.14±1.38)μg·mL^-1,tmax were(2.09±0.57)and(2.19±0.42)h,t1/2 were(1.82±0.16)and(1.71±0.20)h,AUC0→∞were(16.75±3.27)and(17.21±2.95)μg·mL^-1·h.The 90%confidence intervals of Cmax,AUC0→t and AUC0→∞were 86.9%-113.1%,97.0%-116.2%and 88.1%-116.7%,respectively.Conclusion The test preparation and reference preparation of minopronic acid tablets were bioequivalent.

关 键 词：米诺膦酸片 药代动力学 生物等效性 

分 类 号：R97[医药卫生—药品]