【摘要】 目的 :研究辛伐他汀 (SV)的药物动力学 ,评价 SV片剂和胶囊剂的生物等效性。方法 :采用反相高效液相色谱法测定10名志愿受试者单剂量口服 40 m g SV胶囊供试品与 40 m g标准参比制剂后血药浓度的变化。结果 :SV胶囊剂和片剂的AU C分别为 :(15 0 .79± 34.17)与 (15 0 .0 5± 2 6 .78) h· ng/ml,tmax分别为 (2 .35± 0 .41)与 (2 .45± 0 .2 8) h,cmax分别是 (2 5 .6 3±5 .0 9)与 (2 8.14± 8.31) ng/ml。结论 :以 SV胶囊供试品与标准参比制剂 AU C、cmax和 tmax为指标 ,经双单侧 t检验 ,两者为生物等效制剂更多还原

【Abstract】 AIM: To study the pharmacokinetics and relative bioavailability of simvastatin capsule and tablet. METHODS: A single 40 mg oral dose of 2 simvastatin preparations were given respectively to 10 volunteers in an open randomized cross over test. Simvastatin concentration in plasma was assayed by reversed phase high performance liquid chromatography (RP HPLC). RESULTS: The AUC 0→∞ of simvastatin capsule and tablet were (150 79±34 17) and (150 05±26 78) ng·h/ml, t max were (2 35±0 41) and (2 45±0 28) h, c max were (25 63±5 09) and (28 14±8 31) ng/ml respectively. CONCLUSION: The AUC 0→∞ , t max and c max of simvastatin between 2 formulations are evaluated by two side t test and the results show that 2 simvastatin preparations are bioavailability.更多还原