| 米格列奈钙片健康人体药动学研究 |
| 投稿时间：2013-01-31 修订日期：2013-10-15 点此下载全文 |
| 引用本文：恽芸蕾,高守红,樊成辉,缪海均.米格列奈钙片健康人体药动学研究[J].药学实践杂志,2014,32(1):45~48 |
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| 中文摘要:目的 建立测定人血浆中米格列奈钙的LC-MS/MS法,并应用于健康人体药动学研究。方法 30名健康志愿者,随机分为3组(每组10人,男女各半),分别口服米格列奈钙片5、10、20 mg,采用非房室模型统计矩法计算药动学参数。结果 健康受试者单次给药5、10、20 mg后,主要药代动力学参数分别为Cmax(799.5±189.8)、(1 689.8±348.4)和(3 032.9±755.6)ng/ml;tmax(0.38±0.16)、(0.43±0.16)和(0.54±0.26)h;AUC0~10(1 051.3±276.4)、(2 324.5±481.8)和(5 028.8±1 283.6)ng·h/ml;AUC0~∞(1 059.4±278.2)、(2 342.8±488.6)、(5 073.9±1 315.9)ng·h/ml;t1/2(1.80±0.42)、(1.68±0.37)和(1.56±0.19)h。结论 本分析方法准确、灵敏,适用于米格列奈钙片的健康人体药动学研究。 |
| 中文关键词:米格列奈钙 LC-MS/MS 药代动力学 |
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| Pharmacokinetics of mitiglinide calcium tablets in human healthy volunteers |
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| Abstract:Objective To establish a sensitive and specific LC-MS/MS method for the determination of mitiglinide calcium in human plasma, and investigate the pharmacokinetics of mitiglinide calcium tablets in healthy volunteers. Methods 30 healthy volunteers were randomly divided into three groups with 5 men and 5 women in each group. The volunteers in three groups were administrated with single dose of mitiglinide calcium tablets 5, 10, 20 mg, respectively. The pharmacokinetic parameters were calculated by non-compartment model. Results The main pharmacokinetics parameters of mitiglinide in volunteers who were administrated with a single dose of 5, 10, 20 mg were as follows:Cmax(799.5±189.8), (1 689.8±348.4)and(3 032.9±755.6)ng/ml; tmax(0.38±0.16), (0.43±0.16)and(0.54±0.26)h; AUC0-10(1 051.3±276.4), (2 324.5±481.8)and(5 028.8±1 283.6)ng·h/ml; AUC0-∞(1 059.4±278.2), (2 342.8±488.6)and(5 073.9±1 315.9)ng·h/ml; t1/2(1.80±0.42), (1.68±0.37)and(1.56±0.19)h, respectively. Conclusion The present method was accurate, sensitive and reproducible for the determination of mitiglinide levels in human plasma, which was suitable for pharmacokinetic study on mitiglinide tables in human. |
| keywords:mitiglinide calcium LC-MS/MS pharmacokinetics |
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