摘要
制备了盐酸青藤碱渗透泵控释片。以正清风痛宁缓释片为参比制剂,考察其体外释放度和Beagle犬体内吸收情况。自制控释片与参比制剂的主要药动学系数:AUC_(0-t)(11.01±3.2)和(13.06±3.5)μg·ml^(-1)·h,t_(1/2)(27.8±2.6)和(8.6±1.9)h,C_(max)(790.8±126.3)和(1 334.5±150.5)ng/ml。结果表明,自制控释片的体外释放符合零级动力学方程。采用HPLC法测定血药浓度,照Wagner-Nelson法计算药物的体内吸收分数,对响应时间的体外累积释放率线性回归,所得方程的相关系数为0 98。
The sinomenine hydrochloride osmotic pump-controlled release tablets（test preparation） were prepared.The in vitro release and in vivo absorption in Beagle dogs of the prepared tablets were investigated with the Zhengqing Fengtongning sustained-released tablets as the reference preparation.The pharmacokinetic parameters of the prepared tablets and test preparation were as follows：AUC_（0-t）（11.01±3.2） and（13.06±3.5）μg·ml^（-1）·h,t_（1/2）（27.8±2.6） and （8.6±1.9） h,c_（max）（790.8±126.3） and（1 334.5±150.5） ng/ml.The results showed that the in vitro release behavior of the products fitted zero-order kinetic equation.The drug concentration in plasma was determined by HPLC.The in vitro and in vivo correlation of the controlled-release tablets was evaluated by Wagner-Nelson method.The results showed that the correlative coefficient of the test tablets was 0.98.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2011年第2期118-121,共4页
Chinese Journal of Pharmaceuticals
关键词
盐酸青藤碱
渗透泵控释片
体内外相关性
sinomenine hydrochloride
osmotic pump-controlled release tablet
in vitro and in vivo correlation
