国产与进口瑞舒伐他汀钙片在健康人体的药代动力学及生物等效性  

Pharmacokinetics and bioequivalence of domestic and imported rosuvastatin calcium tablets in healthy volunteers

作　　者：肇丽梅[1] 金鑫[2] 王鹏[2] 

机构地区：[1]中国医科大学附属盛京医院药剂科,沈阳110004 [2]沈阳华泰药物研究有限公司,沈阳110015

出　　处：《中国临床药理学杂志》2009年第5期408-411,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价进口与国产瑞舒伐他汀钙片(降血脂药)在健康人体的生物等效性。方法20例健康成年男性受试者随机分组,按自身对照单次口服瑞舒伐他汀钙片20mg后,用UPLC-MS-MS法测定瑞舒伐他汀的血浆浓度,非房室模型法计算各主要药代动力学参数,并进行方差分析和生物等效性评价。结果瑞舒伐他汀片和胶囊的达峰时间tmax分别为(3.35±0.99)和(3.00±1.17)h;达峰浓度Cmax分别为(21.59±15.44)和(16.86±11.03)ng·mL-1;t1/2分别为(11.90±4.34)和(11.27±3.87)h;AUC0-96分别为(173.30±118.18)和(150.58±95.35)ng.h.mL-1;AUC0-∞分别为(175.05±119.02)和(151.88±95.78)ng.h.mL-1。经统计分析,2组间无显著性差异(P>0.05)。结论国产瑞舒伐他汀钙片(浙江京新药业股份有限公司)与进口瑞舒伐他汀钙片(阿斯利康公司)2种制剂生物等效。Objective To observe the pharmacokinetics and bioequivalence of domestic and imported rosuvastatin calcium tablets in healthy volunteets. Methods A single oral dose of 20 mg rosuvastatin calcium was given to 20 healthy volunteers in a randomized cross-over study. Rosuvastatin concertrations in plasma were determined by UPLC-MS-MS methods. Results The main pharmcokinetic parameters of the domestic and imported tablets were as follow：tmax were （3.35±0.99） and （3.00±1.17） h; Cmax were （21.59±15.44） and （16.86±11.03） ng·mL^-1; t1/2were （11.90 ±4.34） and （11.27 ±3.87） h; AUC0-96 were （173.30 ± 118. 18） and （150.58±95.35） ng · h ·mL^-1; AUC0-∞ were （175.05 ± 119.02） and （151.88 ±95.78） ng · h ·mL^-1, respectively. The parameters among them was no significant difference （P 〉 0. 05）. Conclusion There was no significant difference between the parameters of the two groups. The results demonstrated that the two preparations were bioequivalent.

关 键 词：瑞舒伐他汀 超高效液相色谱-串联质谱法 药代动力学 生物等效性 

分 类 号：R969.3[医药卫生—药理学] R972.6[医药卫生—药学]