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学科主题: 药剂学
题名:
2种国产盐酸二甲双胍肠溶胶囊在健康人体的生物等效性
其他题名: Bioequivalence of two domestic praperations of metformin hydrochloride entericcoated capsules in Chinese healthy volunteers
作者: 梁雁1; 许俊羽1; 兰培1; 赵侠1; 周颖1; 崔一民1
关键词: 盐酸二甲双胍肠溶胶囊 ; 高效液相色谱法 ; 生物等效性 ; metformin hydrochloride enteric-coated capsules ; HPLC ; bioequivalence
刊名: 中国临床药理学杂志
发表日期: 2010
DOI: 10.3969/j.issn.1001-6821.2010.04.007
卷: 26, 期:4, 页:267-270
收录类别: 中国科技核心期刊 ; 中文核心期刊 ; CSCD
文章类型: Journal Article
摘要: 目的 研究健康受试者单剂量口服2种国产盐酸二甲双胍(降糖药)肠溶胶囊的药代动力学和生物等效性.方法 采用开放、双周期随机交叉给药方案,22名健康男性受试者单剂量口服2种盐酸二甲双胍肠溶胶囊1 000 mg,用HPLC法测定血浆中二甲双胍浓度,计算其主要药代动力学参数.结果 单剂量口服盐酸二甲双胍肠溶胶囊受试制剂和参比制剂的主要药代动力学参数:AUC_(0-tn) 分别为(9.08±3.59)和(9.09±3.28)μg·h·mL~(-1);AUC_(0-∞)分别为(9.72±3.67)和(9.88±3.62)μg·h·mL~(-1);C_(max)分别为(1.76±0.69)和(1.80±0.63)μg·mL~(-1);t_(max)分别为(3.70±1.08)和(3.77±0.81)h;t_(1/2)分别为(3.03±0.49)和(3.08±0.52)h;F为(103.6±36.9)%.结论 2种制剂具有生物等效性. Objective To study the bioequivalence of two domestic praperations of metformin hydrochloride enteric-coated capsules in Chinese healthy volunteers.Methods A single administration of 1 000 mg metformin hydrochloride enteric-coated capsules of test and reference formulation was given to 22 healthy male volunteers according to an open,randomized,cross-over study.The concentrations of metformin were determined by HPLC method.Results The main pharmacokinetic parameters of test and reference formulation were as follows AUC_(0-tn) were (9.08±3.59)and(9.09±3.28)μg·h·mL~(-1);AUC_(0-∞) were(9.72±3.67)and(9.88±3.62)μg·h·mL~(-1);C_(max) were(1.76±0.69)and(1.80±0.63)μg·mL~(-1);t_(max) were(3.70±1.08)and(3.77±0.81)h;t_(1/2) were(3.03±0.49)and(3.08±0.52)h for test and reference formulation,respectively.The relative bioavailability was(103.6±36.9)%.Conclusion The results of statistical analysis showed that the two formulations were bioequivalence.
语种: 中文
原文出处: 查看原文
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内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/43838
Appears in Collections:北京大学第一临床医学院_药剂科_期刊论文

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作者单位: 1.北京大学,第一医院药剂科,北京,100034
2.北京协和药厂,北京,100055

Recommended Citation:
梁雁,许俊羽,兰培,等. 2种国产盐酸二甲双胍肠溶胶囊在健康人体的生物等效性[J]. 中国临床药理学杂志,2010,26(4):267-270.
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