美洛昔康颗粒剂的人体生物等效性评价  

Bioequivalence assessment of meloxicam granules in Chinese healthy volunteers

作　　者：李佩琼[1] 林明琴[1] 王九辉[1] 吴秀琼[2] 

机构地区：[1]海南医学院药理学教研室,海南海口571101 [2]海南医学院附属医院国家药物临床试验机构,海南海口571101

出　　处：《中国热带医学》2011年第3期334-335,340,共3页China Tropical Medicine

摘　　要：目的评价健康人口服美洛昔康颗粒的生物等效性。方法 20名健康男性志愿者随机交叉单剂量口服美洛昔康颗粒或美洛昔康片15mg后,采用RP-HPLC紫外分析法检测血药浓度。结果美洛昔康颗粒及美洛昔康片的T_(max)分别为(3.3±1.6)和(4.7±1.1)h;C_(max)分别为(0.652±0.109)μg/h·mL和(0.532±0.106)μg/h·mL;T1/2分别为(26.56±11.29)h和(26.87±9.99)h;AUC_(0→96)分别为(20.083±6.182)μg/h·mL和(18.767±6.165)μg/h·mL;AUC_0→∞分别为(23.901±8.624)μg/h·mL和(22.452±7.548)μg/h·mL;美洛昔康颗粒的相对生物利用度F为(113.8±35.5)%。结论美洛昔康颗粒与美洛昔康片具有生物等效性。Aim To evaluate the bioequivalence of meloxicam granules in healthy volunteers.Methods The randomized crossover and self-control study was conducted in 20 healthy volunteers.They were treated with a single oral dose of 15mg of meloxicam granules or a single oral dose of control drug（meloxicam tablets）.The meloxicam concentrations in plasma were detected by RP-HPLC.Results The mean Tmax was（3.3±1.6）h for meloxicam granules and（4.7±1.1） h for meloxicam tablets;the mean Cmax was（0.652±0.109）and（0.532±0.106）μg/mL respectively;T1/2 was（26.56±11.29） and（26.87±9.99）h respectively;AUCO 96 was（20.083±6.182）and（l8.767±6.165）μg·h/mL respectively;AUC0∞was （23.901±8.624）and（22.452±7.548）μg·h/mL respectively;The relative bioavailability of meloxicam granules was（113.8±35.5）%.Conclusion The meloxicam orally suspension is bioequivalent to the meloxicam tablets.

关 键 词：美洛昔康 颗粒剂 HPLC 药动学 生物等效性 

分 类 号：R97[医药卫生—药品]