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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AUC0→10分别为(19.132±4.196),19.001±4.076)g.h.mL 1;AUC0→∞分别为(19.376±4.197,(19.301±4.086)g.h.mL 1;Cmax分别为(6.294±1.819,(6.293±1.973)g.mL 1;Tmax分别为(2.000±0.585),(2.100±0.447)h;克拉维酸钾的AUC0→10分别为(4.333±2.317,(4.275±2.231)g.h.mL 1;AUC0→∞分别为(4.383±2.320,(4.320±2.236)g.h.mL 1;Cmax分别为(1.722±0.961,(1.623±0.813)g.mL 1;Tmax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。
Objective To study the bioequivalence of two amoxicillin and clavulanate potassium capsules. Methods Two-cycle self-control crossover design was used to determine the concentration of amoxicillin and clavulanate potassium in plasma by high performance liquid chromatography-tandem mass spectrometry. Results The AUC0 → 10 of amoxicillin in the test capsule and the reference capsule were (19.132 ± 4.196) and 19.001 ± 4.076 ghmL 1, respectively; AUC0 → ∞ were (19.376 ± 4.197, 19.301 ± 4.086) ghmL 1 ; Cmax were (6.294 ± 1.819, 6.293 ± 1.973) g.mL 1; Tmax was (2.000 ± 0.585) and (2.100 ± 0.447) h respectively; AUC0 → 10 of potassium clavulanate were (4.333 ± 2.317, (4.275 ± 2.231) ghmL 1; AUC0 → ∞ were (4.383 ± 2.320) and (4.320 ± 2.236) ghmL 1 respectively; C max were (1.722 ± 0.961, 1.850 ± 0.651) and (1.950 ± 0.647) h, respectively.The relative bioavailability of amoxicillin and clavulanate potassium in the two preparations were (101.8 ± 14.8)% and (112.5 ± 62.0)%, respectively.Conclusion Two kinds of capsules with biological Equivalence.