阿莫西林分散片人体生物等效性研究  

Study on Human Body Bioequivalence of Amoxicillin Dispersible Tablets

作　　者：李晋峰 沙莹 李佩琼[2] 王九辉[2] 林明琴[2] 

机构地区：[1]海口市制药厂有限公司,海南海口570311 [2]海南医学院药理学教研室,海南海口571101

出　　处：《中国药业》2014年第16期25-26,共2页China Pharmaceuticals

摘　　要：目的 测定健康志愿者阿莫西林血浆药物质量浓度,评价阿莫西林分散片的人体生物等效性。方法 采用双周期交叉试验设计,20名健康男性受试者随机交叉单剂量口服试验制剂与参比制剂,反相高效液相色谱（RP-HPLC）法紫外检测法测定给药前及给药后不同时间点的阿莫西林血药浓度,用DAS 2.0软件计算药代动力学参数并进行统计学分析。结果 参比制剂与试验制剂的达峰时间（tmax）、峰浓度（Cmax）、0~8 h药时曲线下面积（AUC0→8）、0~∞药时曲线下面积（AUC0→∞）分别为（1.35±0.24）h和（1.30±0.25）h,（9.83±2.11）μg/mL和（10.031±1.928）μg/mL,（24.85±3.98）μg/（h·mL）和（25.10±4.41）μg/（h·mL）,（25.56±4.24）μg/（h·mL）和（25.81±4.48）μg/（h·mL）。统计结果显示,试验制剂与参比制剂主要药代动力学参数无显著性差异。试验制剂Cmax,AUC0→8,AUC0→∞的90%可信区间分别为99.5%~105.7%,97.4%~104.4%,96.6%~105.5%。结论 试验制剂与参比制剂具有生物等效性。Objective To determine the plasma concentration of amoxicillin in healthy volunteers and to evaluate the human body bioe- quivalence of Amoxicillin Dispersible Tablets. Methods A single oral dose of tested and reference preparations were given to 20 healthy male volunteers in a randomized two- period cross- over design. The plasma concentrations of amoxicillin before and after administration at different time points were determined by RP- HPLC with UV detection. The pharmacokinetic parameters were calculated and analyzed using the DAS 2.0 software. Results The t C AUC0-15 and AUC0-∞ of the tested and reference preparations were （1.35±0.24）h and （1.30±0.25）h,（9.83±2. 11）μg/mL and （10. 03 ± 1. 93） μg/mL, （24. 85 ± 3, 98 ） μg · h/mL and （25. 10± 4.41）μg ·h/mL, （25.56 ±4.24）μg · h/mL and （25.81±4. 48）μg · h/mL respectively. The statistical analysis results showed that the main pharmacokinetic parameters had no statistically significant differences between the tested and reference preparations. The 90% confidence interval of the tested preparations C AUC0-8 and AUC0-∞ were 99.5% - 105.7% ,97.4% - 104. 4% and 96.6% - 105.5% respectively. Conclusion The tested and reference preparations are bioequivalent.

关 键 词：阿莫西林 分散片 高效液相色谱法 生物等效性 

分 类 号：R969.1[医药卫生—药理学] TQ460.72[医药卫生—药学]