氨氯地平/阿托伐他汀生物等效性研究  

Amlodipine/Atorvastatin Bioequivalence Study

作　　者：王明宇[1] 郑清山 WANG Ming-yu;ZHENG Qing-shan(Department of Pharmacy,the Second Affiliated Hospital of Fujian Medical University,Quanzhou,Fujian Province,362000 China;Department of Pharmacy,Quanzhou Traditional Chinese Hospital,Quanzhou,Fujian Province,362000 China)

机构地区：[1]福建医科大学附属第二医院药学部,福建泉州362000 [2]泉州市中医院药学部,福建泉州362000

出　　处：《中外医疗》2018年第16期113-114,117,共3页China & Foreign Medical Treatment

摘　　要：目的研究氨氯地平/阿托伐他汀生物等效性。方法方便选择2016年6月—2017年6月该院诊治的64名自愿参加该研究的受试者,随机分为对照组和观察组,每组32名。分别口服氨氯地平/阿托伐他汀受试制剂和参比制剂。通过高效液相色谱-串联质谱法,测定了氨氯地平和阿托伐他汀的血浆浓度。通过计算和处理血药浓度数据和统计分析的参数,药时曲线下面积、峰浓度对数转换、方差分析、双单侧t检验,达峰时间分参数检验,进而对比生物等效性。结果氨氯地平的血药浓度线性范围是35~10 000 pg/mg,日内精密度≤5.04%,日间精密度≤7.38%,回收率低,中,高91.24%、89.33%、87.57%,基质效应是99.69%、88.01%、90.83%,生物利用度是(108.63±32.80)%。阿托伐他汀的血清浓度线性范围是35~25 000 pg/mg,日内精密度≤6.12%,日间精密度≤6.17%,回收率低,中,高77.23%、80.85%、82.69%,基质效应是101.25%、99.69%、99.34%,生物利用度为(114.19±71.18)%,两组间差异无统计学意义(P>0.05)。结论氨氯地平/阿托伐他汀具有生物等效性。Objective This paper tries to study the bioequivalence of amlodipine/Atto vastatin. Methods 64 volunteers who participated in the study from June 2016 to June 2017 were convenient selected and randomly divided into a control group and an observation group, with 32 cases in each group. Amlodipine/atorvastatin was administered orally to the test formulation and reference formulation, respectively. Plasma concentrations of amlodipine and atorvastatin were determined by high performance liquid chromatography-tandem mass spectrometry. Through calculation and processing of blood drug concentration data and statistical analysis of parameters, the area under the curve when the drug, peak concentration logarithm transformation, analysis of variance, double one-sided t test, peak time parameter test, and then compare bioequivalence. Results The linear range of serum concentration of amlodipine was 35 -10 000 pg/mg, day precision was no more than 5.04%, day precision was no more than 7.38%, recovery rate was low, medium, high 91.24%,89.33%,87.57%, matrix effect was 99.69%,88.01%,90.83%, bioavailability was（108.63±32.80） %. Serum concentrations of atorvastatin linear range is 35-25 000 pg/mg, 6.12% or less days precision, precision of 6.17% or less in the day, and the recovery rate is low, the high 77.23%,80.85%,82.69%, the matrix effect is 101.25%,99.69%,99.34%, bioavailability of（114.19±71.18） %, there was no statistically significant difference between the two groups（P〈0.05）. Conclusion Amlodipine/atorvastatin is bioequivalent.

关 键 词：氨氯地平 阿托伐他汀 生物等效性 

分 类 号：R5[医药卫生—内科学]