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复方苯磺酸氨氯地平/阿托伐他汀钙片单剂量与多剂量人体药动学研究 被引量:16

Pharmacokinetics of Compound Amlodipine Besylate/Atorvastatin Calcium Tablets in Healthy Volunteers after Oral Administration of Single Dose vs. Multiple Doses
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摘要 目的:研究健康受试者单剂量与多剂量口服复方苯磺酸氨氯地平/阿托伐他汀钙片后的药动学。方法:10名受试者单剂量(10mg)与多剂量(10mg·d-1,连续7d)口服复方苯磺酸氨氯地平/阿托伐他汀钙片后,以高效液相色谱-电喷雾串联质谱(LC-MS/MS)法测定苯磺酸氨氯地平与阿托伐他汀钙血药浓度,利用DAS药动学软件计算药动学参数。结果:单剂量给药后,苯磺酸氨氯地平与阿托伐他汀钙的主要药动学参数分别为:t1/2(53.4±12.9)、(15.4±4.6)h,Cmax(6.7±1.8)、(18.5±4.4)μg·L-1,AUC0~120(298.8±97.1)、(118.3±48.9)μg·h·L-1,AUC0~∞(412.2±131.5)、(120.0±55.1)μg·h·L-1;多剂量给药后,苯磺酸氨氯地平与阿托伐他汀钙的主要药动学参数分别为:t1/2β(49.5±10.3)、(14.4±5.3)h,Cmax(8.7±2.5)、(20.3±5.8)μg·L-1,AUC0~120(451.2±127.1)、(136.3±54.9)μg·h·L-1,AUC0~∞(569.3±165.8)、(139.0±61.3)μg·h·L-1,Cav(2.7±0.6)、(8.3±1.3)μg·L-1,峰谷比(R)1.7±0.4、1.1±0.2。结论:复方苯磺酸氨氯地平/阿托伐他汀钙片中2组分在健康受试者体内的消除速度不随连续给药变化,但连续给药后苯磺酸氨氯地平在体内有轻微蓄积。 OBJECTIVE: To study the pharrnacokinetics of compound amlodipine besylate/atorvastatin calcium tablets (CABACT) following oral administration of single dose vs. multiple doses in healthy volunteers. METHODS: 10 volunteers were administered a single dose of Compound amlodipine besylate/atorvastatin calcium tablets( 10 mg, p.o.)or multiple doses( 10 mg·d^-1, p.o.) for 7 days, respectively. Plasma concentrations of amlodipine besylate and atorvastatin calcium were determined by LC-MS/ MS and the pharmacokinetic parameters were calculated using DAS software. RESULTS: In single-dose study the pharmacokinetic parameters of amlodipine besylate vs. atorvastatin calcium were as follows: t1/2β ( 53.4±12.9 ) h vs. ( 15.4±4.6 ) h; Cmax ( 6.7± 1.8 )μg·L^-1 vs.(18.5±4.4)μg ·L^-1; AUC (298.8-L97.1)μg· h · L^-1 vs. (118.3±48.9)μg·L^-1; AUC0-∞(412.2±131.5) μg· h · L^-1 vs. (120.0±55.1)μg· h · L^-1 In multiple-dose study the pharmacokinetic parameters were as follows: t1/2(49.5±10.3)h vs. (14.4±5.3) h; Cmax(8.7±2.5)μg ·L^-1 vs, (20.3±5.8)μg ·L^-1; AUC0-∞(451.2±127.1)μg ·h·L^-1vs. (136.3±54.9)μg ·h·L^-1; AUC0-∞ (569.3±165.8) μg ·h·L^-1 vs. (139.0±61.3)μg ·h·L^-1; C,,(2.7±0.6),(8.3±1.3)μg L^-1 R(1.7±0.4) vs. (1.1±0.2). CONCLUSION: The elimination rates of amlodipine besylate and atorvastatin calcium do not change after oral administration of multiple doses of CABACT while slight accumulation of amlodipine besylate is founded.
出处 《中国药房》 CAS CSCD 北大核心 2010年第2期130-133,共4页 China Pharmacy
关键词 复方苯磺酸氨氯地平/阿托伐他汀钙片 药动学 高效液相色谱-电喷雾串联质谱法 苯磺酸氨氯地平 阿托伐他汀钙 Compound amlodipine besylate/atorvastatin calcium tablets Pharmacokinetics LC-MS/MS Amlodipine besylate Atorvastatin calcium
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