摘要
本文采用高效液相色谱法对12名男性健康志愿者单剂量口服含100mg无水茶碱的甘氨酸茶碱钠缓释片后血浆中茶碱的浓度进行检测并利用Waguer－Nelson法计算吸收百分率。对体内吸收百分率与体外释放百分率进行相关性研究。结果表明，当采用以浆法，水为溶出介质，转速为100r·min－1，本品体外药物释放与体内药物吸收具有较好的相关性，回归方程为：Y＝0．89＋1．12x，r＝0．9906（n＝6），因此，可以通过控制本品在体外的释放，达到控制体内药物吸收的目的。
In vitro and in vivo correlation of sodium theophylline glycinate (STG) sustainedrelease tabletS was investigated in this test. Plasma concentrations of theophylline in 12 healthymale volunteers were detendned by high performance liquid chromatography after single oraladministraion of STG sustained release tablets (100mg on the basis of an hydrous theophylline).In vivo absorption percentages of theophylline were calculated by Wagner-Nelson method.Invitro drug release profiles were determined in 900ml of water by paddle method at the spead of50r·min-1 and 100 r·min-1, respectively. The results showed that better IVIVC exist whendissolution proceeded in 900ml of water by paddle method at the speed of 100r·min-1. The invitro and in vivo correlation equation is Y=0.89+1.12×(r=0.9906, n=6). In vitro dissolutiontest under the given conditions could be used as the indication of in vivo absorption of STGsustained release tablets.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2000年第3期217-219,共3页
The Chinese Journal of Clinical Pharmacology
