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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
OBJECTIVE: To study the pharmacokinetics of simvastatin (SV) and to evaluate the bioequivalence of SV tablets and capsules. Methods: The change of plasma concentration of 40 volunteers was tested in 40 volunteers with 10 mg volunteers by reverse phase high performance liquid chromatography (RP-HPLC). Results: The AU C of SV capsules and tablets were (15 0 .79 ± 34.17) and (15 0 .05 ± 2 6 .78) h · ng / ml, respectively, with tmax of (2.35 ± 0 .41) and (2.45 ± 0.28) h, cmax were (2.56 ± 5 .0 9) and (2 8.14 ± 8.31) ng / ml, respectively. CONCLUSIONS: According to the double unilateral t-test, the two preparations were bioequivalent with the indexes of AU C, cmax and tmax of SV capsules and standard reference preparations