| 苦参碱胶丸在健康人体内的药动学 |
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| 引用本文： | 张瑞雯,徐红蓉,胡朝英,陈莉,申渊钢,刘罡一,李雪宁,李勤. 苦参碱胶丸在健康人体内的药动学[J]. 中国新药与临床杂志, 2012, 0(1): 29-33 |
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| 作者姓名： | 张瑞雯 徐红蓉 胡朝英 陈莉 申渊钢 刘罡一 李雪宁 李勤 |
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| 作者单位： | 上海市生物医药科技产业促进中心;复旦大学附属中山医院;上海市徐汇区中心医院;双鹤同德堂连锁大药房有限责任公司 |
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| 基金项目： | 上海市科委科研计划项目(08411966700);上海市徐汇区医学科研项目(SHXH201140) |
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| 摘 要： | 目的研究苦参碱在健康人体内的药动学特征。方法 9例健康男性受试者分别给予不同剂量的苦参碱胶丸(100、200或400 mg,服药间隔至少为7 d)后,采用液相色谱-串联质谱(LC-MS/MS)法测定血浆中苦参碱的浓度,经DAS 2.0软件计算药动学参数。结果健康受试者口服苦参碱胶丸100、200或400 mg后,血浆中苦参碱的ρmax、tmax、t1/2、AUC0-t和AUC0-∞分别为(603.84±131.80)、(1 207.27±331.95)和(2 384.44±720.67)μg.L-1,(1.33±0.61)、(1.61±0.78)和(1.67±0.71)h,(8.68±1.32)、(8.28±0.97)和(7.82±0.76)h,(6 203.25±131.80)、(12 816.34±4 665.77)和(20 077.59±6 841.86)μg.h.L-1,(6 375.38±2 253.17)、(13 047.49±4 780.74)和(20 316.03±6 939.34)μg.h.L-1。结论苦参碱在健康人体内的安全性和耐受性良好,血药浓度与药物剂量成正相关。
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| 关 键 词： | 苦参碱 色谱法,高压液相 串联质谱法 药动学 |
Pharmacokinetics of matrine capsules in healthy volunteers |
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| ZHANG Rui-wen,XU Hong-rong,HU Chao-ying,CHEN Li,SHEN Yuan-gang,LIU Gang-yi,LI Xue-ning,LI Qin. Pharmacokinetics of matrine capsules in healthy volunteers[J]. Chinese Journal of New Drugs and Clinical Remedies, 2012, 0(1): 29-33 |
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| Authors: | ZHANG Rui-wen XU Hong-rong HU Chao-ying CHEN Li SHEN Yuan-gang LIU Gang-yi LI Xue-ning LI Qin |
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| Affiliation: | 1(1.Shanghai Center for Biomedicine Development,SHANGHAI 201203,China;2.Zhongshan Hospital,Fudan University,SHANGHAI 200032,China;3.Central Hospital of Shanghai Xuhui District,SHANGHAI 200031,China;4.Shuanghe Tongdetang Technology Co.,Ltd.,Kunshan JIANGSU 215300,China) |
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| Abstract: | AIM To study the pharmacokinetics of matrine capsules in healthy volunteers.METHODS Nine healthy male volunteers were administered with a single dose of 100,200 and 400 mg of matrine capsules,and the interval between administration was at least 7 days.The matrine concentration in plasma was determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS)method,and the relative bioavailability and bioequivalence of the tablets were analyzed by DAS 2.0 software.RESULTS The pharmacokinetic parameters of matrine in plasma of healthy volunteers administered with 100,200 and 400 mg were as follows:ρmax were(603.84 ± 131.80),(1 207.27 ± 331.95)and(2 384.44 ± 720.67)μg·L-1;tmax were(1.33 ± 0.61),(1.61 ±0.78)and(1.67 ± 0.71)h;t1/2 were(8.68 ± 1.32),(8.28 ± 0.97)and(7.82 ± 0.76)h;AUC0-t were(6 203.25 ± 131.80),(12 816.34 ± 4 665.77)and(20 077.59 ± 6 841.86)μg·h·L-1;AUC0-∞ were(6 375.38 ± 2 253.17),(13 047.49 ± 4 780.74)and(20 316.03 ± 6 939.34)μg·h·L-1.CONCLUSION Matrine has good safety and tolerance in healthy male volunteers.Plasma concentration of matrine is positively correlated with dose level. |
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| Keywords: | matrine chromatography,high pressure liquid tandem mass spectrometry pharmaco-kinetics |
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