美洛昔康片在中国健康受试者中的生物等效性研究  

Bioequivalence of meloxicam in Chinese healthy subjects

作　　者：朱艺芳[1] 张全英[1] 王蒙[1] 黄明[1,2] 华雯妍[1,2] 王吉[2] 郑龙生 郭昊 程旻露 ZHU Yi-fang;ZHANG Quan-ying;WANG Meng;HUANG Ming;HUA Wen-yan;WANG Ji;ZHENG Long-sheng;GUO Hao;CHENG Min-lu(Department of Pharmacy,The Second Affiliated Hospital of Soochow University,Suzhou 215004,Jiangsu Province,China;Department of Oncology,The Second Affiliated Hospital of Soochow University,Suzhou 215004,Jiangsu Province,China;Yangtze River Pharmaceutical Group,Taizhou 225321,Jiangsu Province,China;Nanjing Clinical Tech Laboratories Inc.,Nanjing 211100,Jiangsu Province,China)

机构地区：[1]苏州大学附属第二医院药学部,江苏苏州215004 [2]苏州大学附属第二医院肿瘤科,江苏苏州215004 [3]扬子江药业集团有限公司,江苏泰州225321 [4]南京科利泰医药科技有限公司,江苏南京211100

出　　处：《中国临床药理学杂志》2023年第3期405-409,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的 研究美洛昔康片在中国健康人体内的生物等效性。方法 空腹试验24例、餐后试验24例健康受试者,按双周期、自身交叉设计、单剂量口服美洛昔康片受试制剂或参比制剂7.5 mg,用液相色谱-质谱法测定血浆中美洛昔康的血药浓度,用WinNonlin 7.0软件计算药代动力学参数及相对生物利用度,判定两制剂是否等效。结果 在空腹试验中,美洛昔康受试制剂和参比制剂的C_(max)分别为(841.17±160.87)和(812.54±172.43)ng·mL^(-1),AUC_(_(0-t))分别为(2.57±0.84)×10^(4)和(2.45±0.83)×10^(4)h·ng·mL^(-1),AUC_(0-∞)分别为(2.44±0.60)×10^(4)和(2.55±0.94)×10^(4)h·ng·mL^(-1)。在餐后试验中,美洛昔康受试制剂和参比制剂的C_(max)分别为(817.83±123.99)和(808.61±128.85) ng·mL^(-1),AUC_(_(0-t))分别为(2.29±0.57)×10^(4)和(2.29±0.59)×10^(4)h·ng·mL^(-1),AUC_(0-∞)分别为(2.43±0.70)×10^(4)和(2.45±0.74)×10^(4)h·ng·mL^(-1)。受试制剂与参比制剂C_(max)、AUC_(_(0-t))、AUC_(0-∞)几何均值比的90%置信区间均完全落在80.00%~125.00%。结论 2种美洛昔康片在中国健康受试者体内具有生物等效性。Objective To evaluate the bioequivalence of meloxicam tablets in healthy Chinese. Methods Fasting test included 24 subjects, postprandial test included 24 healthy subjects with two cycles, complete repetition, self-cross design, single dose oral meloxicam tablet test preparation or reference preparation 7.5 mg, the concentrations of meloxicam in plasma was determined by liquid chromatography-mass spectrometry. The pharmacokinetic parameters and relative bioavailability were calculated by software WinNonlin 7.0 to determine whether the two preparations were equivalent. Results Under fasting state, the C_(max)of meloxicam test and reference were(841.17±160.87) and(812.54±172.43)ng·mL^(-1);AUC_(0-t)were(2.57±0.84) ×10^(4)and(2.45±0.83) ×10^(4) h·ng·mL^(-1);AUC_(0-∞)were(2.44±0.60) ×10^(4) and(2.55±0.94) ×10^(4) h·ng·mL^(-1);under postprandial state, the C_(max)of meloxicam test and reference were(817.83±123.99) and(808.61±128.85)ng·mL^(-1);AUC_(0-t)were(2.29±0.57) ×10^(4) and(2.29±0.59) ×10^(4) h·ng·mL^(-1);AUC_(0-∞)were(2.43±0.70) ×10^(4) and(2.45±0.74) ×10^(4) h·ng·mL^(-1). The 90% confidence intervals ofC_(max), AUC_(0-t), AUC_(0-∞)geometric mean ratio of test preparation and reference preparation were all within 80. 00%-125. 00%.Conclusion The two meloxicam tablets are bioequivalent in healthy Chinese volunteers.

关 键 词：美洛昔康片 生物等效性 药代动力学 液相色谱-串联质谱法 

分 类 号：R971.1[医药卫生—药品]