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目的:研究po洛伐他汀胶囊与美降之片后,洛伐他汀在血浆中的药动学与相对生物利用度。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po100mg洛伐他汀胶囊与美降之片后,洛伐他汀血药浓度变化情况,计算药动学参数与相对生物利用度,并以配对t检验与双单侧t检验进行统计分析。结果:两制剂的AUC分别是:(334.8±40.9)ng·h·ml-1与(343.2±54.2)ng·h·ml-1,tmax分别为:(2.5±0.4)h与(2.5±0.3)h,cmax分别是:(45.6±4.8)ng·ml-1与(43.3±5.9)ng·ml-1。配对t检验与双单侧t检验结果表明:AUC,cmax,tmax均无显著性差异(P>0.05)。结论:洛伐他汀胶囊与美降之片为生物等效制剂;洛伐他汀胶囊的相对生物利用度为(98.45±10.18)%。
OBJECTIVE: To study the pharmacokinetics and relative bioavailability of lovastatin in plasma after po lovastatin capsules and melphalan tablets. Methods: The change of lovastatin plasma concentration after single-dose po100mg lovastatin capsules and beauty tablets were measured in 10 volunteers by RP-HPLC. The pharmacokinetic parameters and relative bioavailability , And paired t-test and double unilateral t test for statistical analysis. Results: The AUC of the two preparations were (334.8 ± 40.9) ng · h · ml-1 and (343.2 ± 54.2) ng · h · ml-1, respectively. 5 ± 0.4) h and (2.5 ± 0.3) h, cmax were (45.6 ± 4.8) ng · ml-1 and (43.3 ± 5.9) ng · ml -1. Paired t-test and double-sided t-test showed that there was no significant difference in AUC, cmax, tmax (P> 0.05). Conclusion: The lovastatin capsules and the beauty tablets are bioequivalent. The relative bioavailability of lovastatin capsules is (98.45 ± 10.18)%.