CAJ | 학술논문

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( C max )、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。
목적：측정건강지원자아막서림혈장약물질량농도，평개아막서림분산편적인체생물등효성。방법채용쌍주기교차시험설계，20명건강남성수시자수궤교차단제량구복시험제제여삼비제제，반상고효액상색보（RP - HPLC）법자외검측법측정급약전급급약후불동시간점적아막서림혈약농도，용 DAS 2.0연건계산약대동역학삼수병진행통계학분석。결과삼비제제여시험제제적체봉시간( tmax )、봉농도( C max )、0~8 h 약시곡선하면적( AUC0→8)、0~∞약시곡선하면적( AUC0→∞)분별위（1.35±0.24）h 화（1.30±0.25）h，（9.83±2.11）μg / mL 화（10.031±1.928）μg / mL，（24.85±3.98）μg /(h·mL)화（25.10±4.41）μg /(h·mL)，（25.56±4.24）μg /（h·mL）화（25.81±4.48）μg /（h·mL）。통계결과현시，시험제제여삼비제제주요약대동역학삼수무현저성차이。시험제제 Cmax，AUC0→8，AUC0→∞적90%가신구간분별위99.5%~105.7%，97.4%~104.4%，96.6%~105.5%。결론시험제제여삼비제제구유생물등효성。
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 ad-ministration 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 tmax,Cmax,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% con-fidence interval of the tested preparations Cmax,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.