2种盐酸氨溴索制剂的人体生物等效性研究  

Bioequivalence Study of 2 Kinds of Ambroxol Hydrochloride Preparations

作　　者：王曦[1] 何海霞[2] 

机构地区：[1]贵州遵义医院,遵义市563002 [2]重庆医科大学附属第一医院临床药理研究室,重庆市400016

出　　处：《中国药房》2011年第6期516-518,共3页China Pharmacy

摘　　要：目的:研究盐酸氨溴索颗粒与盐酸氨溴索片的人体生物等效性。方法:18名男性健康志愿者随机交叉单剂量口服盐酸氨溴索颗粒(受试制剂)或盐酸氨溴索片(参比制剂)60mg后,采用高效液相色谱法测定血药浓度,用3p97软件计算二者的药动学参数,并评价其生物等效性。结果:受试制剂与参比制剂的药-时曲线符合口服吸收一室模型。二者药动学参数分别为:t1/2Ke(4.05±1.89)、(4.39±2.14)h;tma(x2.00±0.48)、(1.75±0.71)h;cma(x154.59±65.64)、(153.95±70.21)ng·mL-1;AUC0～2(4954.96±419.86)、(951.63±463.38)ng·h·mL-1;AUC0～∞(1098.64±469.63)、(1158.98±505.57)ng·h·mL-1。盐酸氨溴索颗粒的相对生物利用度为(100.35±14.82)%,经方差分析、双单侧t检验及(1-2α)置信区间法统计分析,各药动学参数无显著性差异(P>0.05)。结论:盐酸氨溴索颗粒与盐酸氨溴索片具有生物等效性。OBJECTIVE: To study the bioequivalence of Ambroxol hydrochloride granules and Ambroxol hydrochloride tablets. METHODS: A randomized crossover design was performed in 18 healthy volunteers. In the two study periods, a single oral dose of Ambroxol hydrochloride granules (trial preparation) 60 mg or Ambroxol hydrochloride tablets(reference preparation) 60 mg were administered to each volunteers. Plasma concentrations of ambroxol hydrochloride were measured by HPLC. The pharmacokinetic parameters as well as bio...

关 键 词：盐酸氨溴索颗粒 盐酸氨溴索片 高效液相色谱法 生物等效性 药动学 

分 类 号：R969.1[医药卫生—药理学]