阿莫西林克拉维酸钾胶囊的生物等效性研究

Bioequivalence of Amoxicillin Sodium and Clavutante Potassium Capsules in Chinese Healthy Volunteers

关键词:  阿莫西林克拉维酸钾胶囊  相对生物利用度  生物等效性  高效液相色谱-串联质谱法

Key words:  Amoxicillin sodium and Clavutante Potassium capsules  relative bioavailability  bioequivalence  HPLC/MS/MS

摘要:

目的 研究两种阿莫西林克拉维酸钾胶囊的生物等效性。方法 采用2制剂2周期自身对照交叉试验设计，利用高效液相色谱-串联质谱法测定血浆中阿莫西林和克拉维酸钾药物浓度。结果 受试胶囊和参比胶囊中阿莫西林的AUC_0→10分别为(19.132±4.196)，(19.001±4.076)mg·h·mL^-1；AUC_0→∞分别为(19.376±4.197)，(19.301±4.086)mg·h·mL^-1；C_max分别为(6.294±1.819)，(6.293±1.973)mg·mL^-1；T_max分别为(2.000±0.585)，(2.100±0.447)h；克拉维酸钾的AUC_0→10分别为(4.333±2.317)，(4.275±2.231)mg·h·mL^-1；AUC_0→∞分别为(4.383±2.320)，(4.320±2.236)mg·h·mL^-1；C_max分别为(1.722±0.961)，(1.623±0.813)mg·mL^-1；T_max分别为(1.850±0.651)，(1.950±0.647)h；两制剂的阿莫西林和克拉维酸钾的相对生物利用度分别为(101.8±14.8)%，(112.5±62.0)%。结论 两种胶囊具生物等效性。

Abstract:

OBJECTIVE To evaluate the bioequivalence of Amoxicillin sodium and Clavutante Potassium capsules in Chinese healthy volunteers. METHODS Concentrations of Amoxicillin sodium and Clavutante Potassium in plasma were determined by HPLC/MS/MS after healthy volunteers received a single dose of test dispersible capsule and reference capsule in two-treatment, two-period, crossover design. RESULTS The main pharmacokinetic parameters of Amoxicillin sodium and Clavutante Potassium capsules were as follows: AUC_0→10 (Amoxicillin) were (19.132±4.196) and (19.001±4.076)mg·h·mL^-1; AUC_0→∞(Amoxicillin) were (19.376±4.197) and (19.301±4.086)mg·h·mL^-1; C_max(Amoxicillin) were (6.294±1.819) and (6.293±1.973)mg·mL^-1; T_max(Amoxicillin) were (2.000±0.585) and (2.100±0.447)h; AUC_0→10(Clavutante) were (4.333±2.317) and (4.275±2.231)mg·h·mL^-1；AUC_0→∞(Clavutante) were (4.383±2.320) and (4.320±2.236)mg·h·mL^-1; C_max(Clavutante) were (1.722±0.961) and (1.623±0.813)mg·mL^-1; T_max(Clavutante) were (1.850±0.651) and (1.950±0.647)h; The relative bioavailability of Amoxicillin sodium and Clavutante Potassium were (101.8±14.8)% and (112.5±62.0)%. CONCLUSION The results of statistic analysis show that two capsules of Amoxicillin sodium and Clavutante Potassium were bioequivalent.