盐酸氨溴索缓释片体内外相关性研究

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。

Studies on the correlation between release in vitro and absorption in vivo of ambroxol hydrochloride sustained-release tablets

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.