| 米格列奈钙胶囊的人体生物等效性研究 |
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| 引用本文： | 马忠英,乔逸,贾艳艳,杨林,丁莉坤,文爱东.米格列奈钙胶囊的人体生物等效性研究[J].中国药房,2010(18):1667-1669. |
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| 作者姓名： | 马忠英 乔逸 贾艳艳 杨林 丁莉坤 文爱东 |
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| 作者单位： | 第四军医大学西京医院药剂科; |
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| 摘 要： | 目的:研究2种米格列奈制剂的人体生物等效性。方法:20名健康男性志愿者随机交叉单剂量口服米格列奈钙胶囊(受试制剂)与米格列奈钙片(参比制剂)10mg后,以液-质联用法测定人血浆中米格列奈钙的浓度,并用DAS2.1.1软件计算药动学参数和生物利用度。结果:受试者口服米格列奈受试制剂与参比制剂后的主要人体药动学参数分别为:Cma(x1056.7±292.7)、(1033.9±283.0)ng·mL-1,tma(x0.50±0.23)、(0.48±0.14)h,t1/2(β2.38±0.81)、(2.58±0.76)h,AUC0～1(51764.6±472.3)、(1658.6±305.0)ng·h·mL-1,AUC0～∞(1773.7±473.9)、(1671.3±307.4)ng·h·mL-1。受试制剂相对于参比制剂的生物利用度为104.9%。结论:受试制剂与参比制剂生物等效。
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| 关 键 词： | 米格列奈钙胶囊 米格列奈钙片 液-质联用法 药动学 生物等效性 |
Study on Bioequivalence of Mitiglinide Calcium Capsule in Human Volunteers |
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| MA Zhong-ying,QIAO Yi,JIA Yan-yan,YANG Lin,DING Li-kun,WEN Ai-dong.Study on Bioequivalence of Mitiglinide Calcium Capsule in Human Volunteers[J].China Pharmacy,2010(18):1667-1669. |
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| Authors: | MA Zhong-ying QIAO Yi JIA Yan-yan YANG Lin DING Li-kun WEN Ai-dong |
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| Institution: | (Dept. of Pharmacy, Xijing Hospital of Fourth Military Medical University, Xi’an 710033, China) |
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| Abstract: | OBJECTIVE: To study the bioequivalence of two kinds of mitiglinide preparations in human volunteers. METHODS: A total of 20 healthy male volunteers were enrolled in a randomized crossover study in which the subjects were randomly assigned to receive single oral dose of 10 mg mitiglinide calcium capsule (test preparation) or mitiglinide calcium tablet (reference preparation). The plasma concentrations of mitiglinide were determined by LC-MS and the pharmacokinetic parameters and bioavailability were evaluate... |
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| Keywords: | Mitiglinide calcium capsule Mitiglinide calcium tablet LC-MS Pharmacokinetics Bioequivalence |
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