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辛伐他汀药物动力学及生物利用度 被引量:16

Pharmacokinetics and bioavailability of simvastatin capsule
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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 。 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.
出处 《中国临床药学杂志》 CAS 2000年第5期289-291,共3页 Chinese Journal of Clinical Pharmacy
关键词 辛伐他汀 相对生物利用度 药物动力学 simvastatin relative bioavailability pharmacokinetics
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参考文献3

  • 1Pentikainen JP, Saraheimo M, Schwartz JI, et al. Comparative pharmacokinetics of lovastatin, simvastatin and pravastatin in humans. J Clin Pharmacol, 1992, 32:136
  • 2Davidson MH, Stein EA, Dujovre CA, et al. The efficacy and six-week tolerability of simvastatin 80 and 160 mg/day. American J of Cardiol, 1997, 79(Jan):38
  • 3Stubbs RJ, Schwartz MS, Gerson RJ, et al. Comparison of plasma profiles lovastatin (mevinolin), simvastatin (epistatin) and pravastatin (eptastatin) in the dog. Drug Invest, 1990, 2:18

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