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米格列奈钙片健康人体药动学研究

恽芸蕾,  高守红,  樊成辉,  缪海均

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文章导航 > 药学实践与服务  > 2014 >  32(1): 45-48
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]. 药学实践与服务, 2014, 32(1): 45-48. doi: 10.3969/j.issn.1006-0111.2014.01.011
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]. 药学实践与服务, 2014, 32(1): 45-48. doi: 10.3969/j.issn.1006-0111.2014.01.011
shu
YUN Yunlei, GAO Shouhong, Fan Chenghui, MIAO Haijun. Pharmacokinetics of mitiglinide calcium tablets in human healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(1): 45-48. doi: 10.3969/j.issn.1006-0111.2014.01.011
Citation: YUN Yunlei, GAO Shouhong, Fan Chenghui, MIAO Haijun. Pharmacokinetics of mitiglinide calcium tablets in human healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(1): 45-48. doi: 10.3969/j.issn.1006-0111.2014.01.011
shu

米格列奈钙片健康人体药动学研究

doi: 10.3969/j.issn.1006-0111.2014.01.011

  • 第二军医大学附属长征医院药学部, 上海 200003

Pharmacokinetics of mitiglinide calcium tablets in human healthy volunteers

  • Department of Pharmacy, Changzheng Hospital Affiliated to Second Military Medical University, Shanghai 200003, China

  • 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。
    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.
  • [1] Kumashiro N,Yoshihara T,Kanazawa Y,et al.Long-term effect of combination therapy with mitiglinide and once daily insulin glargine in patients who were successfully switched from intensive insulin therapy in short-termstudy[J].Endocr J,2007,54(1):163-166.
    [2] Sunaga Y,Gonoi T,Shibasaki T,et al.The efects ofmitiglinide (KAD-1229)a new antidiabetic drug,on ATP-sensitive-K channels and insulin secretion:comparison with the sulfonylureas and nateglinide[J].Eur J Pharmacol,2001,431(1):119.
    [3] Lushan Y,Su Z.Determination of mitiglinide in rat plasma by high performance liquid chromatography with UV detection[J]. Chromatogr B Anal Technol Biomed Life Sci,2006,834(1-2):204-207.
    [4] Jin HW,Yu QX.SPE and LC-ESI-MS for quantitative analysis of mitiglinide in human plasma in a bioequivalence study[J].Chromatographia,2009,70(11-12):1715-1719.
    [5] Liang J,Tian Y,Zhang Z,et al.High-performance liquid chromatography/electrospray ionization mass spectrometry determination of mitiglinide in human plasma and its pharmacokinetics[J].J Mass Spectrom,2007,42(2):171-177.
    [6] Cai S, Huo TG, Feng WY, et al. Quantitative determination of mitiglinide in human plasma by ultra-performance liquid chromatography/electrosprayionization tandem mass spectrometry[J]. J Chromatogr B, 2008,868,83-87.
    [7] Zhang Y, Ding L, Tian Y, et al. Liquid chromatography-electrospray ionization tandem mass spectrometry for the quantification of mitiglinide in human plasma:validation and its application to pharmacokinetic studies[J]. Biomed Chromatogr,2008,22(8):873-878.
    [8] 赵秀丽,王淑民,武 峰,等.米格列奈钙片在健康人体内的药代动力学[J].中国临床药理学杂志,2010,9(26):53-55.
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出版历程
  • 收稿日期:  2013-01-31
  • 修回日期:  2013-10-15

米格列奈钙片健康人体药动学研究

doi: 10.3969/j.issn.1006-0111.2014.01.011
  • 第二军医大学附属长征医院药学部, 上海 200003
  • 收稿日期: 2013-01-31
  • 修回日期: 2013-10-15

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。

English Abstract

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]. 药学实践与服务, 2014, 32(1): 45-48. doi: 10.3969/j.issn.1006-0111.2014.01.011
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]. 药学实践与服务, 2014, 32(1): 45-48. doi: 10.3969/j.issn.1006-0111.2014.01.011
shu
YUN Yunlei, GAO Shouhong, Fan Chenghui, MIAO Haijun. Pharmacokinetics of mitiglinide calcium tablets in human healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(1): 45-48. doi: 10.3969/j.issn.1006-0111.2014.01.011
Citation: YUN Yunlei, GAO Shouhong, Fan Chenghui, MIAO Haijun. Pharmacokinetics of mitiglinide calcium tablets in human healthy volunteers[J]. Journal of Pharmaceutical Practice and Service, 2014, 32(1): 45-48. doi: 10.3969/j.issn.1006-0111.2014.01.011
shu

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