美洛昔康胶囊人体生物等效性的研究  

Bioequivalence of Meloxicam capsule in healthy volunteers

作　　者：黄玉友[1] 任小群[1] 宋林[1] 蒋学华[1] 何毅[2] 王凌[1] 

机构地区：[1]四川大学华西药学院,四川成都610041 [2]成都市血液中心,四川成都610041

出　　处：《华西药学杂志》2013年第3期272-274,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的评价美洛昔康胶囊(受试制剂)和美洛昔康片(参比制剂)在健康人体的生物等效性。方法采用HPLC-UV法,测定人血浆中美洛昔康的浓度,并进行方法学验证;采用随机交叉自身前后对照试验设计,20名受试者分别口服受试制剂和参比制剂15 mg后,测定美洛昔康的血药浓度,计算药动学参数,评价两制剂的生物等效性。结果美洛昔康胶囊和美洛昔康片的t1/2分别为24.61±10.46、26.56±7.57 h,Cmax分别为2.45±0.33、2.49±0.37μg.mL-1,Tmax分别为4.58±1.35、5.05±1.51 h;AUC0→t分别为76.57±17.71、84.12±19.91μg.h.mL-1。美洛昔康胶囊的相对生物利用度为92.8%±17.7%。结论两制剂在健康中国人体内具有生物等效性。OBJECTIVE To study the bioequivalence of Meloxicam capsules（test preparation） and Meloxicam tablets（reference preparation） in Chinese healthy volunteers.METHODS An HPLC-UV assay method for determining the concentration of meloxicam in human plasma was developed and validated.This method was applied to a clinical pharmacokinetic study of meloxicam in 20 healthy subjects using a two-stage,cross over study design.The subjects sequentially received single oral doses of 15 mg of meloxicam（reference or test preparations）.During each stage,multiple blood samples were collected and the drug plasma concentrations were measured.The pharmacokinetic parameters i.e.AUC,t1/2 were calculated and utilized to evaluate the bioequivalence between the two preparations.RESULTS The t1/2 for reference and test products were 26.56±7.57 and 24.61±10.46 h,respectively,while the Cmax were 2.49±0.37,2.45±0.33 μg·mL^-1 for reference and test preparation,respectively.The Tmax for reference and test products were 5.05±1.51,4.58±1.35 h,respectively,while the AUC0→t were 84.12±19.91,76.57±17.71 μg·h·mL^-1 for reference and test preparations,respectively.The relative bioavailability of Meloxicam Capsules is 92.8%±17.7%.CONCLUSION The test preparation is bioequivalent with the reference preparation in healthy volunteers.

关 键 词：美洛昔康胶囊 高效液相色谱-紫外 生物等效性 

分 类 号：R917[医药卫生—药物分析学]