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

doi:10.3969/j.issn.1006-0111.2014.01.011

留言板

尊敬的读者、作者、审稿人, 关于本刊的投稿、审稿、编辑和出版的任何问题, 您可以本页添加留言。我们将尽快给您答复。谢谢您的支持!

姓名
邮箱
手机号码
标题
留言内容
验证码

x 关闭永久关闭

《药学实践与服务》杂志目前不收取审稿费、版面费、加急费等费用，如收到邮件声称是编辑部X编辑，要求加作者微信的，请谨防财产损失！编辑部用于作者校对时绑定微信的邮件通过[email protected]发送，标题是《药学实践与服务》XML数字出版服务微信绑定，请区分开。

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

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

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

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C_max(799.5±189.8)、(1 689.8±348.4)和(3 032.9±755.6)ng/ml;t_max(0.38±0.16)、(0.43±0.16)和(0.54±0.26)h;AUC_0~10(1 051.3±276.4)、(2 324.5±481.8)和(5 028.8±1 283.6)ng·h/ml;AUC_0~∞(1 059.4±278.2)、(2 342.8±488.6)、(5 073.9±1 315.9)ng·h/ml;t_1/2(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。
- 米格列奈钙 /
- LC-MS/MS /
- 药代动力学
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:C_max(799.5±189.8), (1 689.8±348.4)and(3 032.9±755.6)ng/ml; t_max(0.38±0.16), (0.43±0.16)and(0.54±0.26)h; AUC_0-10(1 051.3±276.4), (2 324.5±481.8)and(5 028.8±1 283.6)ng·h/ml; AUC_0-∞(1 059.4±278.2), (2 342.8±488.6)and(5 073.9±1 315.9)ng·h/ml; t_1/2(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.
- mitiglinide calcium /
- LC-MS/MS /
- pharmacokinetics

[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.

[1]	冯一帆, 严啸东, 张文彬, 李炳锋, 郭美丽. 菸花苷长期给药对脑缺血再灌注损伤大鼠神经功能的影响 . 药学实践与服务, 2025, 43(): 1-7. doi: 10.12206/j.issn.2097-2024.202407038
[2]	崔亚玲, 吴琼, 马良煜, 胡北, 姚东, 许子华. 肝素钠肌醇烟酸酯乳膏中肌醇烟酸酯皮肤药动学研究 . 药学实践与服务, 2025, 43(1): 6-9, 21. doi: 10.12206/j.issn.2097-2024.202404006
[3]	魏雨辰, 田家盛, 王道鑫, 凌期盛, 王治, 缪朝玉. 烟酰胺单核苷酸口服给药对高血压大鼠的影响 . 药学实践与服务, 2025, 43(5): 1-9. doi: 10.12206/j.issn.2097-2024.202412006
[4]	李想, 陆鸿远, 张明玉, 高欢, 姚东, 许子华. 米格列醇激活UCP1介导棕色脂肪改善冷暴露小鼠损伤的研究 . 药学实践与服务, 2025, 43(1): 1-5, 16. doi: 10.12206/j.issn.2097-2024.202404005
[5]	晁亮, 王辉, 沈淑琦, 游飘雪, 冀凯宏, 洪战英. 基于UHPLC-Q/TOF-MS代谢组学策略的葛根-知母药对防治阿尔茨海默病的药效与作用机制研究 . 药学实践与服务, 2025, 43(1): 30-40. doi: 10.12206/j.issn.2097-2024.202409035
[6]	夏哲炜, 曾垣烨, 朱海菲, 李育, 陈啸飞. 核磁共振磷谱法测定磷酸氢钙咀嚼片中药物含量 . 药学实践与服务, 2024, 42(9): 399-401, 406. doi: 10.12206/j.issn.2097-2024.202404063
[7]	张艺昕, 关欣怡, 王博宁, 闻俊, 洪战英. 二氢吡啶类钙离子拮抗药物手性分析及其立体选择性药动学研究进展 . 药学实践与服务, 2024, 42(8): 319-324. doi: 10.12206/j.issn.2097-2024.202308062
[8]	陈方剑, 骆锦前, 王志君, 胡叶帅, 孙煜昕, 宋洪杰. HPLC-MS/MS同时测定感冒安颗粒中5种黄酮成分的含量 . 药学实践与服务, 2024, 42(9): 402-406. doi: 10.12206/j.issn.2097-2024.202403030
[9]	李丹, 戴贤春, 王芳珍, 陈奕含, 杨萍, 刘继勇. HPLC-MS/MS测定当归六黄汤中4种不同成分的含量 . 药学实践与服务, 2024, 42(6): 248-252, 266. doi: 10.12206/j.issn.2097-2024.202305007
[10]	陈炳辰, 佟达丰, 万苗, 闫飞虎, 姚建忠. UPLC-MS/MS法测定小鼠血浆中紫杉醇脂肪酸酯前药及其药代动力学研究 . 药学实践与服务, 2024, 42(8): 341-345. doi: 10.12206/j.issn.2097-2024.202404082

点击查看大图

计量

文章访问数: 2954
HTML全文浏览量: 304
PDF下载量: 68
被引次数: 0

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

关键词:

米格列奈钙 /

LC-MS/MS /

药代动力学

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C_max(799.5±189.8)、(1 689.8±348.4)和(3 032.9±755.6)ng/ml;t_max(0.38±0.16)、(0.43±0.16)和(0.54±0.26)h;AUC_0~10(1 051.3±276.4)、(2 324.5±481.8)和(5 028.8±1 283.6)ng·h/ml;AUC_0~∞(1 059.4±278.2)、(2 342.8±488.6)、(5 073.9±1 315.9)ng·h/ml;t_1/2(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。