| 盐酸利托君片在中国健康志愿者体内的生物等效性 |
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| 引用本文： | 陶春蕾,许钒,宋欣,周燕.盐酸利托君片在中国健康志愿者体内的生物等效性[J].中国新药杂志,2011(8). |
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| 作者姓名： | 陶春蕾 许钒 宋欣 周燕 |
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| 作者单位： | 安徽中医学院;安徽万邦医药科技有限公司; |
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| 摘 要： | 目的:研究不同生产厂家生产的利托君片的生物等效性。方法:根据身高体重相近原则,18例健康女性受试者采用双周期两交叉给药方案,分别一次性口服2片(10 mg.片-1)试验盐酸利托君片或参比盐酸利托君片,用LC-MS/MS内标法测定健康受试者血浆中盐酸利托君浓度,采用DAS 2.0.1软件计算药动学参数,并进行2种制剂的生物等效性评价。结果:经药动学参数计算其参比药t1/2=(2.623±1.223)h,Cmax=(12.425±6.891)ng·mL-1,Tmax=(0.769±0.555)h,AUC0~t=(28.416±9.102)ng·h·mL-1,AUC0~∞=(33.199±12.338)ng·h·mL-1;试验制剂t1/2=(2.539±0.670)h,Cmax=(14.475±11.262)ng·mL-1,Tmax=(0.741±0.509)h,AUC0~t=(30.499±11.402)ng·h·mL-1、AUC0~∞=(34.258±12.094)ng·h·mL-1。试验制剂的相对生物利用度AUC0~t=(109.6±23.0)%,AUC0~∞=(108.0±26.2)%。结论:受试制剂与参比...
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| 关 键 词： | 利托君 LC-MS/MS 生物等效性 |
Bioequivalence of ritodrine hydrochloride tablets in Chinese healthy volunteers |
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| TAO Chun-lei,XU Fan,SONG Xin,ZHOU Yan.Bioequivalence of ritodrine hydrochloride tablets in Chinese healthy volunteers[J].Chinese Journal of New Drugs,2011(8). |
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| Authors: | TAO Chun-lei XU Fan SONG Xin ZHOU Yan |
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| Institution: | TAO Chun-lei1,XU Fan1,SONG Xin2,ZHOU Yan2(1 Anhui College of Traditional Chinese Medicine,Hefei 230031,China,2 Anhui Wanbang Medical Technology Co.,Ltd.,Hefei 230088,China) |
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| Abstract: | Objective:To investigate the bioequivalence of different ritodrine tablets produced by different manufacturers.Methods: According to the similarity of height and weight,a biperiodic two cross test was designed.Totally 18 healthy female subjects were orally administered with 2 pieces(10 mg per piece) of test or reference ritodrine hydrochloride tablets.Then,ritodrine HCl concentrations in plasma were determined by LC-MS/MS method with an internal standard.The pharmacokinetic parameters were calculated using ... |
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| Keywords: | ritodrine LC-MS/MS bioequivalence |
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