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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。
Sinomenine hydrochloride osmotic pump controlled release tablets were prepared. Taking Zhengqingfengtongning Sustained-release Tablets as reference preparation, the in vitro release and the in vivo absorption of Beagle dogs were investigated. The main pharmacokinetic parameters of homemade controlled-release tablets and reference preparations were AUC 0 t -1 (11.01 ± 3.2) and (13.06 ± 3.5) μg · ml -1 · h -1, 27.8 ± 2.6) and (8.6 ± 1.9) h, C max (790.8 ± 126.3) and (1 334.5 ± 150.5) ng / ml, respectively. The results showed that self-made controlled release tablets in vitro release in line with the zero-order kinetic equation. The plasma concentration was determined by HPLC. The in vivo absorption fraction of drug was calculated by Wagner-Nelson method. The linear regression of cumulative release rate of response time in vitro was obtained. The correlation coefficient of the equation was.