| 灯盏花素分散片人体生物等效性研究 |
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| 引用本文： | 贾 云,张 军,储继红,谈恒山,蒋 萌,熊宁宁,居文政. 灯盏花素分散片人体生物等效性研究[J]. 药学与临床研究, 2010, 18(4): 347-349 |
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| 作者姓名： | 贾 云 张 军 储继红 谈恒山 蒋 萌 熊宁宁 居文政 |
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| 作者单位： | 1. 扬子江药业集团有限公司,泰州,225321
2. 南京中医药大学附属医院临床药理科,南京,210029 |
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| 基金项目： | 江苏省中医药领军人才项目 |
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| 摘 要： | 目的：以灯盏花素普通片为对照,研究灯盏花素分散片在健康人体内的相对生物利用度和生物等效性。方法：20名健康成年男性志愿者采用随机分组、自身交叉对照试验设计,用LC-MS法测定血浆中灯盏乙素苷元,线性范围为0.013~3.32μg.mL-1;平均回收率89.7%-100.5%,日内和日间精密度均小于12.0%。结果：灯盏花素分散片和普通片的主要药动学参数：tmax：（7.1±2.2）h和（6.6±1.9）h;Cmax：（0.87±0.37）mg.L-1和（1.0±0.44）mg.L-1;AUC（0-24h）：（4.68±1.53）mg·h·L^-1和（5.08±1.50）mg·h·L^-1;AUC（0-∞）：（4.78±1.55）mg·h·L^-1和（5.18±1.54）mg·h·L^-1.h;t1/2：（4.36±2.07）h和（4.09±1.35）h。以AUC（0-24h）计算的受试制剂的相对生物利用度为（93.1±16.9）%。结论：两种制剂的Cmax和AUC（0-24h）经方差分析和双单侧t检验其结果生物等效。
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| 关 键 词： | 灯盏花素分散片 高效液相-质谱联用法 药代动力学 生物等效性 |
| 收稿时间： | 2010-04-12 |
| 修稿时间： | 2010-05-11 |
Bioequivalence Study of Breviscapine Dispersible Tablets in Chinese Healthy Volunteers |
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| JIA Yun,ZHANG Jun,CHU Ji-hong,TAN Hen-shang,JIANG Meng,XIONG Ning-ning and JU Wen-zheng. Bioequivalence Study of Breviscapine Dispersible Tablets in Chinese Healthy Volunteers[J]. Pharmacertical and Clinical Research, 2010, 18(4): 347-349 |
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| Authors: | JIA Yun ZHANG Jun CHU Ji-hong TAN Hen-shang JIANG Meng XIONG Ning-ning JU Wen-zheng |
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| Affiliation: | Yangtze River Pharmaceutical Group, Taizhou, Jiangsu Province, 225321;Department of Clinic Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, China;Department of Clinic Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, China;Department of Clinic Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, China;Department of Clinic Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, China;Department of Clinic Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, China;Department of Clinic Pharmacology, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Nanjing 210029, China |
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| Abstract: | |
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| Keywords: | Breviscapine dispersible tablets LC-MS Pharmacokinetics Bioequivalence |
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