刘国良,程刚,邹梅娟,郝秀华,王琳,逄凤娟
LIU Guo-liang1; CHENG Gang1; ZOU Mei-juan1; HAO Xiu-hua2; WANG Lin1; Pang Feng-juan3(1. School of Pharmacy;

• 1:沈阳药科大学药学院
• 2:沈阳药科大学药学院
• 3:沈阳药科大学药学院
• 4:吉林大学药学院

摘要(Abstract)：

目的考察盐酸氨溴索缓释片体外释放度与体内吸收的相关性。方法应用释放度测定法研究盐酸氨溴索缓释片体外释药行为 ,采用HPLC法测定盐酸氨溴索缓释制剂在家犬体内的血药浓度 ,按照Wagner Nelson公式计算药物的吸收分数。 结果 3种自制盐酸氨溴索缓释片与参比制剂生物等效 ,以药物累积吸收百分数 f(t)与相应时刻的体外累积释放百分数F(t)建立的一元线性回归方程 ,参比制剂与 3种自制制剂的体内外相关系数分别为 0 969、0 979、0 970和 0 983。结论盐酸氨溴索缓释片的体外释放度与体内吸收具有显著的相关性。
Objective To study the in vitro and in vivo correlation of ambroxol hydrochloride sustained-release tablets.Methods The release tests in vitro were used to evaluate the behavior in vitro of the sustained-release tablets.HPLC was applied to determining the concentration of ambroxol hydrochloride in dogs' plasma,and the absorption percentage was calculated according to the Wagner-Nelson's formula.Results Ambroxol hydrochloride sustained-release tablets were bioequivalent with the reference preparation.The linear regressive equation was established between the absorption percentage in vivo and the accumulative release percentage in vitro of ambroxol hydrochloride,and the correlative coefficients of reference preparation and three self-prepared preparations are 0.969 9,0.979 3.0.970 8 and 0.983 0,respectively.Conclusion The results suggest that there is a significant correlation between the absorption in vivo and the accumulative release percentage in vitro of ambroxol hydrochloride sustained-release tablets.

关键词(KeyWords)： 盐酸氨溴索缓释片;释放度;血药浓度;体内外相关性
ambroxol hydrochloride sustained release tablets; in vitro release; in vivo absorption; in vitro in vivo correlation

Abstract:

Keywords:

基金项目(Foundation):

作者(Authors): 刘国良,程刚,邹梅娟,郝秀华,王琳,逄凤娟
LIU Guo-liang1; CHENG Gang1; ZOU Mei-juan1; HAO Xiu-hua2; WANG Lin1; Pang Feng-juan3(1. School of Pharmacy;

参考文献(References)：

• [1]陈耀,张辉跃,兰品英.痰之保克治疗呼吸系统感染临床疗效观察[J].药学实践杂志,1997,15(2):83.
• [2]罗慰蒽,甘春兰,朱元钰,等.沐舒痰临床疗效验证63例总结[J].中国新药杂志,1992,1(5):23-24.
• [3]贾伟元.氨溴索合成路线图解[J].中国医药工业杂志,1995,26(5):235-237.
• [4]王电军,尹邦良,喻风雷.盐酸氨溴索在体外循环肺损伤中的保护作用[J].中国现代医学杂志,2003,13(6):17-19.
• [5]AbuIzzaKA ,GarciaContrerasL ,LuDR .PreparationandevaluationofsustainedreleaseAZT loadedmicro spheres:Optimizationofthereleasecharacteristicsusingresponsesurfacemethodology[J].JPharmSci,1996,85:144-149.
• [6]DoB ,RobinetS ,PradeauD ,etal.Applicationofcentralcompositedesignsforoptimizationofthechro matographicseparationofmonomethylarsonateanddimethylarsinateandofselenomethionineandselenitebyion-pairchromatographycoupledwith plasmamassspectrometricdetection[J].Analyst,2001,126:594-601.
• [7]史爱欣,李可欣,王淑民.国产盐酸氨溴索胶囊人体生物等效性[J].中国医院药学杂志,2000,20(12):709-711.
• [8]范国荣,胡晋红,李珍.多剂量口服盐酸氨溴索缓释胶囊的人体药代动力学及相对生物利用度[J].中国药理学通报,2000,16(4):469-471.